|Year : 2014 | Volume
| Issue : 3 | Page : 172-175
A combined administration of Aragvādādi kaṣāyam and Syrup Talekt induced skin rashes
Manjunath Ajanal1, BS Prasad2
1 Department of Dravyaguna and Medical Research Center, Rajiv Gandhi Education Society's Ayurveda Medical College and PG Research Centre, Ron, India
2 Department of Panchakarma, KLEU Shri BMK Ayurved Mahavidhyalaya, Belgaum, Karnataka, India
|Date of Web Publication||17-Nov-2014|
Research Officer cum Assistant Professor Department of Dravyaguna and Medical Research Center Rajiv Gandhi Education Society's Ayurveda Medical College and PG Research Centre, Ron 82 209, Karnataka
Source of Support: KLE Ayurveda Hospital, Peripheral
Pharmacovigilance Centre for Ayurveda Siddha and Unani Drugs
Belgaum, Karnataka, Conflict of Interest: None
Clinical trial registration CTRI/2010/091/001164, 18-08-2010
It is a common notion among people in India that herbal or Ayurvedic products are safe and do not produce any adverse effect. This is not true since Ayurveda has evaded many adverse effects which occur by combination of herbs. This axiom is potentiated by our report that occurs in the form of skin rashes. A 20-year-old South Indian female of Pittakapha prakṛti (constitution) after beginning therapy with Aragvādādi kaṣāyam (ARK) (poly-herbal formulation) and Syrup Talekt (poly-herbal patent formulation) for the treatment of recurrent incidence of abscess. Rash disappeared after stopping the suspected drug and treatment with Vibhîtakî kaṣāyam (decoction of Terminilia bellarica) and Śatadhauta ghṛtam . Possible and probable (score 6) were the causality according to WHO-Uppsala Monitoring Centre and Naranjo's Adverse Drug Reaction Probability Scale and grouped under type-B reaction. To the best of our knowledge, this is the first case of skin rashes which seen after administration of ARK and Syrup Talekt. This report highlights the need of implementation of pharmacovigilance center in the hospital level and additional research in the field of skin toxicity of ARK and Syrup Talekt.
Keywords: Abscess, Aragwadadi kashaya, Ayurveda, skin rashes, Talekt
|How to cite this article:|
Ajanal M, Prasad B S. A combined administration of Aragvādādi kaṣāyam and Syrup Talekt induced skin rashes. Ancient Sci Life 2014;33:172-5
| Background|| |
Rashes are most common cutaneous adverse drug reactions (ADRs) to any type of drugs and appear within 1 st week of the drug therapy.  Overall incidence of allergic drug reactions is variously reported as being between 2% and 25%.  Common causes of skin rashes are infective, drug, sensitive skin, and some of known cutaneous eruption by penicillin, phenytoin, sulfonamide, sulfonylurea, thiazide, antituberculous drugs, antimalarials, penicillamine, ampicillin, amoxicillin, etc.  There are references in Ayurvedic literature on the way in which drug induced consequences. Such as manifestation of skin diseases on external administration of juice of Bhallātaka (Semecarpus anacardium),  by suppressing the urge of Chardi (vomiting),  Vamana mithyayoga (inadequate administration of emesis).  There are few recently published ADR reports on Ayurvedic drugs as DaŚāṅga lepa (poly-herbal formulation) induced skin rashes  and thyroiditis, followed by ginger consumption. 
Aragvādādi (ARK) is well-known herbaceous decoction of Ayurveda used to treat various skin ailments.  The details of the formulation is listed in [Table 1]. Chardi (Emesis), Viṣavikāṛa (morbidity due to poisonous substance), Kaphavikāra (disorders due to vitiation of Kaphadoṣa), Prameha (urinary disorders), Kaṇḍu (itching), Duṣṭavraṇa (nonhealing ulcer), Kuṣṭha (skin disease).
|Table 1: List of ingredients of Aragvādādi kaṣāyam with its respective official part |
Click here to view
Syrup Talekt is another patent herbal medication of Himalaya Drug Company. Each 5 ml of syrup contains extracts of 18 mg of Aragvāda (Cassia fistula Linn.) and Haridrāa (Curcuma longa Linn.), 16 mg of Nimba (Azadirachta indica A. Juss.) and Guḍuci (Tinospora cordifolia (Willd.) Miers ex Hook. f. & Thoms.) and 15.5 mg of Triphalā (combination of Terminalia chebula Retz., Terminalia bellirica (Gaertn) Roxb., Phyllanthus emblica Linn.), Viḍaṅga (Emblica ribes Burm. f.), Bhṛṅgarāja (Eclipta alba (L.) Hassk.), Kirātatikta (Swertia chirayita Karsten) with methyl paraben sodium propyl and sodium benzoate being chemical preservatives. The company which manufactures this syrup claims this drug to be effective in the management of skin disorders. 
These two formulations are believed to be safe because of lack of reports suggesting dermatological manifestations. This report discusses a case of skin rash in a patient on oral administration of ARK and Syrup Talekt.
| Case report|| |
A 20-year-old South Indian female of Pittakapha prakṛti (constitution), who had was a resident of Belgaum, Karnataka since birth, consulted us for abscess in her right thigh that had developed 3-month back together with fever and myalgia. Her history includes regular incidence of abscess once in 6-9 months. She was not known to have allergy to any food or drugs.
A month back she was on Serratiopeptidase with diclofenac sodium (15:200 mg) with a dose of 1-tablet b.i.d. for 7-day and previous day of the event patient was on ARK with dose of 3 tsf t.i.d. along with water. On the next day along with previous drug, Syrup Talekt was administered with a dose of 3 tsf with water before food in thrice daily.
Adverse drug event
On oral administration of ARK 3 tsf with water and Syrup Talekt 3 tsf with water, she has presented widespread skin rashes involving the abdomen, thighs, and upper arms [Figure 1] and [Figure 2]. No mucosal involvement was noted. The remainder of the physical examination was normal with no signs of conjunctivitis.
The skin itching and rashes were gradually reduced 1 day after the discontinuation of Syrup Talekt and ARK and treatment with Vibhîtakî kaṣāya (decoction of Terminilia bellarica) for washing followed by application of Śatadhautaghṛtam and oral medications of Vibhîtakî kaṣāya (decoction of T. bellarica) 3 tsf before food and Candanāsava 3 tsf with water after food t.i.d. A complete cure was seen on 5 th day of the above treatment. Patient's written consent was taken for documentation and publication of this case.
| Discussion|| |
We hereby presented a case of skin rash after consuming ARK and Syrup Talekt. There were a temporal relationship and positive dechallenge, which points toward the association between the suspected formulation and the event. No such reaction was noticed by any other patient on taking Syrup Talekt and ARK of the same batch. This points toward the susceptibility of the patient toward the reaction.
Causality assessment was done by WHO-Uppsala Monitoring Centre Causality Assessment Scale and Naranjo's ADR Probability Scale the score of which are possible and probable (score 6) with Syrup Talekt and ARK administration respectively and severity was moderate. Dermatological reaction to ARK was not known, in fact the present formulation is known for its vast therapeutic applications on skin disorders  hence, in present event cause is difficult to trace. The paraben is a well-known preservative used in kaṣāyam and syrup, it is known to cause skin irritation and contact dermatitis in selective paraben allergy individuals. , In present drug event, the involvement of preservative was ruled out as patient does not have a history of hypersensitivity to any of such preservatives. Hence, cause can be attributed to increased dose of administration of Aragvāda (Cassia fistula Linn.) Nimba (Azadirachta indica A. Juss.) and Guḍūci (Tinospora cordifolia (Willd.)) which are common ingredients of both the formulations. Although, these drugs have not reported causing toxicity in increased dose of administration, but there is a remote possibility of administration of higher dose of these drugs might have caused the event. The firm conclusion can be drawn only after the re-challenging technique. In the present case, the re-challenging technique was not followed due to the patient discomfort and ethical issues.
This may be a good example for unpredictable or idiosyncratic reaction because it is very hard to predict cause and effect relation in modern pharmacology or Ayurvedic pharmacology as has been reported in the case of administration of DaŚāṅga lepa induced skin rashes  so it may be grouped under type-B type of ADR.
Such unpredictable adverse reactions are not necessarily due to errors or negligence. It is difficult to predict host susceptibility to such response and thus it becomes very important to document, evaluate and report such reactions, so that its recurrence can be prevented in the future.
The detection of unknown and unexpected relationship between drug exposure and adverse events is one of the major challenges of pharmacovigilance. It is likely for an unexpected adverse reaction to go unnoticed until a very substantial number of patients have been adversely affected. Early detection of unknown and unexpected adverse reactions depends upon proper identification of signals and voluntary reporting system. Identifying and reporting such events plays an important role in preventing its recurrence.
Developing a practice of identifying ADR and its reporting will play an important role in a successful implementation of National Pharmacovigilance Program for Ayurveda Siddha and Unani (ASU) drugs.
This case has been reported to National Pharmacovigilance Centre for ASU drugs, Jamanagar, India on 08.01.2011.
| Acknowledgments|| |
We are grateful to Dr. Avinash Kadam and Dr. Amith K coordinator of MRC, KLE Ayurveda Hospital Belgaum, Karnataka and Peripheral Pharmacovigilance Centre for Ayurveda Siddha and Unani Drugs, Karnataka, for their support in preparing manuscript. We also extend our thanks to Dr. I. B. Kotturshetti Principal & CMO, RGES'S Ayurvedic Medical College and PG Research Centre, Ron, for their encouragement in publishing this report.
| References|| |
Nayak S, Acharjya B. Adverse cutaneous drug reaction. Indian J Dermatol 2008;53:2-8.
Salil KB, Parantapa S, Arunabha R. Drug interactions. In: Das PK, editor. Pharmacology. 2nd ed. New Delhi: Elsevier; 2003. p. 52.
Ibia EO, Schwartz RH, Wiedermann BL. Antibiotic rashes in children: A survey in a private practice setting. Arch Dermatol 2000;136:849-54.
Pandey GS, editor. Bhavaprakasha Nighantu of Bhavamishra. Haritakyadivarga, Verse 228-31. 1st ed. Varanasi: Chaukhamba Bharati Academy; Reprinted 2004. p. 138.
Acharya JT, editor. "7th Chapter" Sutra Stana. Charaka Samhita. 5th ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2006. p. 43.
Acharya JT, editor. "1st Chapter" Siddhi Stana. Charaka Samhita. 5th ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2006. p. 680.
Ajanal M, Kadam A, Nayak SU. Skin rash on site of application of Dashanga lepa (polyherbal formulation): A rare and unexpected drug reaction. Anc Sci Life 2012;31:129-31.
Sanavi S, Afshar R. Subacute thyroiditis following ginger (Zingiber officinale) consumption. Int J Ayurveda Res 2010;1:47-8.
Paradakara HB, editor. "15th Adhyaya" Sutra Stana. Ashtanga Hrudayam. 9th ed. Varanasi: Chaukhambha Orientalia; 2005. p. 235.
Himalaya Drug Company Products. Available from: http://www.himalayahealthcare.com/products/pharmaceuticals/talekt-gh.htm. [Last accessed on 2014 Apr 26].
Schorr WF. Paraben allergy. A cause of intractable dermatitis. JAMA 1968;204:859-62.
Zirwas MJ, Stechschulte SA. Moisturizer allergy: Diagnosis and management. J Clin Aesthet Dermatol 2008;1:38-44.
[Figure 1], [Figure 2]