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 Table of Contents  
CLINICAL TRIAL
Year : 2017  |  Volume : 37  |  Issue : 1  |  Page : 45-50

A randomized double blind controlled study evaluating efficacy & Safety of vatika enriched coconut hair oil on hair health in women with hair fall and dandruff


1 Department of Skin and Venereal Diseases, J. J. Hospital, Mumbai, Maharashtra, India
2 Medical Affairs and Clinical Research, Dabur Research and Development Centre, Dabur India Ltd, Sahibabad, Ghaziabad, Uttar Pradesh, India
3 Healthcare Research, Dabur Research and Development Centre, Dabur India Ltd, Sahibabad, Ghaziabad, Uttar Pradesh, India
4 Personal Care Division, Dabur Research and Development Centre, Dabur India Ltd, Sahibabad, Ghaziabad, Uttar Pradesh, India

Date of Web Publication13-Jul-2018

Correspondence Address:
Arun Gupta
Dabur Research and Development Centre, Dabur India Ltd., Plot No 22, Site IV, Sahibabad, Ghaziabad - 201 010, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/asl.ASL_142_17

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  Abstract 

Background: Hair loss can be a stressful experience often associated with images of reduced self-worth, more in women than men. Dandruff may be associated with hair loss. Objective: To investigate the safety and efficacy of Vatika Enriched Coconut Hair Oil (VHO) on hair health in women with hair fall and dandruff. Methods: This was a double-blind, controlled study of 8 week duration conducted at Dermatology outpatient department of J.J. Hospital, Mumbai. Forty four (44) healthy female subjects with at least shoulder length hair and complaints of hair fall and dandruff were randomized equally into 2 groups. Members of one group massaged their scalps with VHO twice a week at night followed by washing the hair in morning with a supplied neutral shampoo. Control group used a marketed brand of coconut oil in a similar manner. Main Outcome Measures: Effect of VHO on hair fall, dandruff and hair health parameters such as shininess, blackness, roughness and tensile strength of hair. Secondary outcome assessed was overall subject safety. Subjects were followed up at days 14, 28, 42 and 56 days. Results: VHO was found safe and effective in controlling hair fall, dandruff and improving the overall condition of hair. VHO was found clinically better than coconut oil in controlling hair fall, dandruff, improving the tensile strength of hair and the shininess, blackness and roughness of hair. Global evaluation of therapeutic response by subjects and physician also showed a better efficacy of VHO than coconut hair oil. None of the subjects exhibited sensitivity to any of the study products and no adverse events were reported during the course of the study. Conclusions: Vatika Enriched Coconut Hair Oil is safe and effective in controlling hair fall and dandruff and improving the overall hair-health.

Keywords: Ayurveda, dandruff, hair fall, hair health, hair oil, herbal, tensile strength


How to cite this article:
Kura M M, Gupta A, Srivastava R, Luthra S K. A randomized double blind controlled study evaluating efficacy & Safety of vatika enriched coconut hair oil on hair health in women with hair fall and dandruff. Ancient Sci Life 2017;37:45-50

How to cite this URL:
Kura M M, Gupta A, Srivastava R, Luthra S K. A randomized double blind controlled study evaluating efficacy & Safety of vatika enriched coconut hair oil on hair health in women with hair fall and dandruff. Ancient Sci Life [serial online] 2017 [cited 2018 Dec 16];37:45-50. Available from: http://www.ancientscienceoflife.org/text.asp?2017/37/1/45/236541


  Introduction Top


Hair is considered to be a major component of an individual's general appearance. Shiny hair with a smooth texture is generally perceived to be healthy.[1] Hair loss and dandruff are common dermatological problems encountered in clinical settings; often one being associated with the other.[2] Hair loss can be a stressful experience and may have direct and indirect causes, such as increased stress, in women, nutritional imbalances and genetic factors.[3] The psychological impact of hair loss may be associated with images of reduced self-worth more in women than in men.[4]

Hair fall and other hair afflictions are described in Ayurveda under the aegis of Khālitya (alopecia), Pālitya (canitites/premature greying), Dāruṇaka/Aruṇaśikhā (Dandruff) and Indralupta/Ruhya(baldness) etc., in the chapters on minor diseases (Kṣudraroga). Plants have been widely used for hair growth promotion since ancient times as reported in Ayurveda, Chinese and Unani systems of medicine. Ayurveda describes a specific category of hair tonics or 'Keśya' herbs that are beneficial for overall hair health. Various treatment modalities to improve hair health such as śirobhyaṅga and śirovasti have been described.[5],[6],[7]

Vatika Enriched Coconut Hair Oil (VHO) is a coconut oil based Ayurvedic hair oil formulation comprising goodness of Keśya herbs such as Madayantikā (Lawsonia inermis L.), Triphalā(powder of Āmalakī, Phyllanthus emblica L.; Harītakī, Terminalia chebula Retz.; Vibhītakī, Terminalia bellirica Gaertn. Roxb.), Gandhamūli (Hedychium spicatum Sm. in A. Rees), Nimba (Azadirachta indica (Gaertn.) Roxb), Brāhmī (Centella asiatica (L.) Urban) andRosemary (Rosmarinus officinalis L.) that are used traditionally in Ayurveda to promote hair health.[8],[9]

This clinical study evaluated the efficacy of two different formulations of Vatika Enriched Coconut Hair Oil (old and new formulations) on parameters of hair health such as hair fall and dandruff in comparison to a marketed brand of coconut hair oil. The current paper, however, discusses the results of the existing marketed products only, i.e.; the new formulation of VHO and the marketed brand of coconut hair oil.


  Methods Top


The study was designed to be randomized, double blind, and parallel group. It was conducted in healthy women at a single site in Maharashtra after obtaining the approval from Ethics Committee (IEC-Grant Medical College and Sir J.J. Group of Hospitals on 28/09/2007). The study was registered retrospectively with the CTRI. The CTRI number for this study is - CTRI/2017/01/007645 [Registered on: 06/01/2017].

Study subjects

Females aged between 18 to 35 years attending the Outpatient Department of Dermatology, J. J. Hospital, Mumbai were screened for eligibility. Healthy non pregnant/non lactating females with at least shoulder length hair having complaints of mild to moderate dandruff and hair fall; and who were using commercial brands of hair oil and shampoo at least twice a week were considered eligible for enrollment. Each subject expressed her willingness to follow study procedures. Women of child-bearing potential were required to use a medically sound form of birth control during the study (male/female condom, diaphragm plus a spermicidal agent etc.)

Reasons for exclusion from study participation included pre-existing hair or scalp disease other than hair fall, concomitant medications or treatments affecting the hair (minoxidil, chemotherapy etc.), use of styling tools, hair dyes, hair perming etc., excessive exposure to sun, chemicals in pools or salt in oceans, pregnancy, lactation, refusal to use contraceptive measures, history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinal, neurological disorders, drug addiction, headaches, hepatitis, carriers of the Hepatitis B surface antigen (Hbs-Ag) or Hepatitis C antibody, HIV + status, participation in another clinical trial <12 weeks before the screening visit, allergy/intolerance to the investigational product or any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study.

Study products

VHO (HO/702) manufactured by Dabur India Ltd. is prepared from powders/extracts derived from herbs such as Madayantikā (Lawsonia inermis L.), Āmalakī (Phyllanthus emblica L.), Harītakī (Terminalia chebula Retz.), Vibhītakī (Terminalia bellirica (Gaertn.) Roxb.), Nimba (Azadirachta indica (Gaertn.) Roxb.), Maṇḍūkaparṇī (Centella asiatica (L.) Urban), Gandhamūli(Hedychium spicatum Sm. in A. Rees); and oil derived from lemon (Citrus limon (L.) Osbeck), Rosemary (Rosmarinus officinalis L.) coconut (Cocos nucifera L.); cow's milk, phospholipids and Vitamin E. Control group used a marketed brand of coconut oil (H0/703).

Treatment schedule

Subjects were instructed to apply the assigned hair oil twice a week at night followed by washing the hair in the morning with a supplied neutral shampoo. They were advised to keep the applied hair oil for at least 12 h and maintain a gap of at least two days in between two applications. They were also advised not to use any commercial hair care products for the study duration.

Study end points

Therapeutic end point assessed was treatment with the study products for 8 weeks with or without improvement in the clinical condition of subject. Clinical end points assessed were changes in scores of the following:

  1. Hair growth
  2. Hair fall
  3. Dandruff
  4. Shininess of hair
  5. Blackness of hair
  6. Roughness or dryness of hair
  7. Tangling or detangling of hair
  8. Tensile strength of hair shaft.


Hair growth was assessed by Trichoscan technique. Hair fall was assessed by manual count and by pick and pluck method. Tensile strength was assessed subjectively and by breaking force method using Dia-stron Tensile Tester (DTT). Tangling and detangling were assessed using comb method and self-assessment. Dandruff, Roughness or dryness of hair, shininess and blackness were assessed subjectively.

Study procedures

Subjects were screened for eligibility on day -7. Eligible subjects were randomized in a double blind fashion to either VHO or Control groups after one week wash out period (baseline, day 0). Baseline procedures included a routine physical examination, a skin sensitivity test to rule out sensitivity to study products and assessment of vitals and hair health parameters.

Recruited subjects were followed up across four visits from baseline at days 14, 28, 42 and 56.

All the parameters of hair health were assessed at baseline and days 28 and 56. Manual assessment of hair fall, self-assessment of dandruff, shininess, roughness, blackness, tensile strength and tangling and de-tangling of hair was done on day 14 and 42. Clinical safety was assessed at each follow up visit. Study product dispensing was done at baseline and on day 28.

Statistical analysis

The statistical analyses were done using repeated measures analysis of Variances (ANOVA) followed by the t-test for treatment comparison at different time points within and across the groups at 5% level of significance.


  Results Top


Subject enrollment: A total of 44 female subjects between 18-35 years and having at least shoulder length hair were randomized to either VHO (n = 22) or Control groups (n = 22). There were no drop outs and all the subjects completed the study.

Effect on hair growth

Assessment by Trichoscan technique: Both VHO and coconut oil were effective in improving hair count, hair density, the anagen and vellus hair counts and vellus hair density. They were also effective in reducing the telogen and terminal hair counts and the terminal hair density. There was no significant difference between the effects of both the groups on any of the parameters of hair growth.

Effect on hair fall

Assessment by manual count

The test was done on clean and dried hair. A comb of measured dimensions of teeth was run through the entire length of hair from back to front five times so as to equally cover the entire area of scalp. The hairs stuck in the comb were collected in plastic bags and counted. Significant reduction in hair fall was visible earlier (day 14) in VHO group compared to coconut oil group (day 28). More than 50% improvement in hair fall from baseline was observed on day 28 in subjects using VHO compared to 30.17 % in coconut oil group [Table 1].
Table 1: Effect on hair fall-manual counts (mean±standard deviation with percentage improvement)

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Assessment by pick and pluck method

The test was done on clean and dried hair. 10 hairs were gripped 2 cm away from scalp and plucked using blunt forceps. The mean hair fall assessed by pick and pluck method was found to improve in both the groups at day 28. VHO showed more than 25% reduction in hair fall at day 28 as compared to 15% with coconut oil [Table 2].
Table 2: Effect on hair fall - pick and pluck method (mean±standard deviation with percentage improvement)

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Effect on dandruff

Dandruff was assessed subjectively on a scale of 0-10 with higher scores indicating dandruff as bad as a participant could imagine. A significant control in dandruff was observed in both the groups from day 14 onwards till EOS. At day 28, VHO treated subjects showed more than 50% improvement in dandruff compared to 42.59% in Control group [Table 3].
Table 3: Effect on dandruff (self-assessment) (mean±standard deviation with percentage improvement)

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Effects on Other Parameters of Hair Health

Shininess

Shininess of hair was assessed subjectively on a scale of 0-10 where decrease in score indicated a better effect of hair oil. Significant improvement in shininess of hair was observed in both the groups from day 28 onwards. At study completion, there was 47.62 and 43.86% improvement in shininess from baseline, respectively in groups.

Roughness or dryness of hair

Roughness of hair was assessed subjectively on a scale of 0-10 where a higher score indicated hair roughest possible a subject could imagine. Significant improvement in Roughness or dryness of hair was observed from day 28 (visit 4) onwards with 48 and 45.35% change from baseline at study completion in the study groups, respectively.

Blackness

Blackness of hair was assessed subjectively on a scale of 0-10, a decrease in score indicated improvement in blackness. Significant improvement was observed in Blackness of hair from day 28 onwards with 32.83 and 21.39% change from baseline in the study groups, respectively at study completion.

Tangling of hair

Tangling of hair was assessed on a scale of 0-10 where lesser scores indicated tangle free hair. Significant improvement in tangling of hair was observed in both the groups from day 28 onwards with 39.66 and 44.03% change, respectively in the groups from baseline at study completion.

Effect on tensile strength

Self-assessment of tensile strength

Tensile strength of hair was assessed on a scale of 0-10; where higher scores indicated minimal force applied to break the hair. The change in mean score of tensile strength was significant day 28 onwards in both the groups. At EOS, 35.05 and 32.16% improvements, respectively were reported in tensile strength in VHO and coconut oil groups.

Assessment by breaking force method

The average breaking force for hair samples from subjects was found to increase significantly in both the groups from visit 4 onwards. The mean change in tensile strength in VHO and coconut oil groups were 21.30 and 11.29%, respectively at study completion [Table 4].
Table 4: Effect on various parameters of hair health (mean±standard deviation with percentage improvement)

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Global evaluation for overall hair condition and therapeutic response

Global evaluation of therapeutic response was carried out on VAS of 0-100 where higher scores indicated a better relief. Based on subject's perception, overall therapeutic response to VHO was found to be better than coconut oil. A higher number of subjects in VHO group (64.46%) felt relief in the overall hair condition at the end of 42 days of therapy as compared to coconut oil (42.26%).

Based on Physicians' global evaluation, the therapeutic response was found to be better in VHO group with 71.92% subjects showing significant improvement in overall hair condition as compared to 49.65% subjects in coconut oil group at study completion [Table 5].
Table 5: Global evaluation for overall hair condition and therapeutic response (mean±standard deviation with percentage improvement)

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Assessment of safety

None of the subjects exhibited sensitivity to any of the study products and no adverse events were reported during the course of the study.


  Discussion Top


Hair serves as a cushion against external shocks, as a means to keep the head warm, and a shield to protect the scalp from ultraviolet rays. Hair also helps in excreting harmful heavy metals, such as arsenic, mercury, zinc etc., from the body. Above all, hairs are the mean of enhancing the aesthetic appearance of a person. In cases of severe hair loss, there can be negative psychological consequences, such as lowered self-esteem, anger, depression, social withdrawal and inappropriate personal relations, with these effects being visibly more in women than men.[5],[10]

Ayurvedic texts have described the various conditions affecting hair health and their management. A specific category of 'Keśya' herbs or hair tonics have been described in Ayurveda that are beneficial for overall hair health.[8],[9] Plants have been widely used for hair growth promotion since ancient times as reported in Ayurveda, Chinese and Unani systems of medicine.[11] Presently, when the global interest in exploring herbal solutions to health problems is gaining momentum, the herbs from Ayurveda are being explored for herbal solutions to hair problems. Vatika Enriched Coconut Hair Oil is an Ayurvedic Coconut Hair Oil formulation comprising goodness of herbs traditionally documented to be beneficial for hair health.

VHO comprises goodness of Keśya herbs such as Madayantikā, Āmalakī, Harītakī, Vibhītakī, Nimba, Brahmī/Maṇḍūkaparṇī, Gandhamūli, Rosemary etc., that are used traditionally in Ayurveda to promote hair health. Madayantikā, Āmalakī, Harītakī, Maṇḍūkaparṇī and Gandhamūli are useful in management of itching and dermal infections.[12],[13],[14],[15],[16],[17],[18],[19],[20]Madayantikā is historically applied to hair to combat lice and dandruff.[21]Āmalakī, Harītakī, Vibhītakī along with Madayantikā are used to preserve natural color/blackness of hair.[22] Lemon oil is useful in management of external parasites.[23] It has exhibited remarkable miticidal activity in in vitro and in vivo applications.[24]Nimba is attributed with Keśya properties and is useful in dandruff (Dāruṇaka/Aruṇaśikhā).[25],[26]

Rosemary oil is indicated traditionally in management of alopecia.[27] Topical application of rosemary leaf extract has been reported to reverse the interruption in hair growth induced by testosterone treatment in mice. Extract of the plant has shown antiandrogenic activity and may help in preventing hair loss.[28] Coconut oil has been found to reduce the protein loss remarkably from both undamaged and damaged hair and is known to have a positive benefit on tensile properties of hair.[29] Processing of these herbs with coconut oil and cow's milk may have contributed towards improving the efficacy of VHO.

The present study evaluated the effects of VHO on hair fall, dandruff and parameters of hair health such as shininess, blackness and tensile strength etc. , in comparison to coconut oil. Hair fall assessed by manual counts and pick and pluck method showed more than and 50% and 25% reduction, respectively from baseline in VHO group at day 28 compared to 30.17% and 15.94% with coconut oil. VHO also showed more than 50% improvement in dandruff from baseline compared to 42.59% with coconut oil at day 28. Statistically, both VHO and coconut oil were found to be comparably effective in controlling hair fall and dandruff and in improving the assessed parameters of hair health. However, VHO was found to be clinically better than coconut oil in controlling hair fall, dandruff and improving the tensile strength, shininess, roughness blackness and overall condition of hair on global patient and physicians' evaluation. None of the subjects exhibited sensitivity to any of the study products and no adverse events were reported during the course of the study. Dermal safety of VHO has also been established in preclinical studies.[30],[31]


  Conclusions Top


Vatika Enriched Coconut Hair Oil (VHO) and coconut hair oil were found safe and effective in controlling hair fall, dandruff and improving the overall condition of hair. However, Vatika Enriched Coconut Hair Oil was found clinically better than coconut oil in controlling hair fall and dandruff and improving the tensile strength, shininess, blackness, roughness and overall condition of hair. Global evaluation of therapeutic response by subjects and physician also showed a better efficacy of Vatika Enriched Coconut Hair Oil on hair health parameters. No adverse events were reported during the study.

Based on the results of this study, it can be concluded that Vatika Enriched Coconut Hair Oil is safe and effective in improving overall hair health especially with respect to hair fall and dandruff.

Acknowledgment

Author wish to acknowledge the scientific/technical contributions of Dr. K. R. Kohli, Dr. G. Sharma and Dr. S. Nipanikar employed with Dabur during the conduct of study and; Dr. Kapila Chawda, JJ Hospital, Mumbai for study coordination.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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