Journal of Research in Ayurvedic Sciences

Register      Login

VOLUME 3 , ISSUE 1 ( January-March, 2019 ) > List of Articles

PROTOCOL

A Study Protocol of a Prospective, Open-label, Single-arm, Clinical Trial to Evaluate the Efficacy of Classical Ayurveda Medicines in the Management of Vicharchika (Atopic Eczema)

Bhagwan Sahay Sharma, Bidhan Mahajon, Bhogavalli Chandra Sekhara Rao

Keywords : Nalpamaradi taila, Panchatikta ghrita, Protocol, Vicharchika,Ayurveda

Citation Information : Sharma BS, Mahajon B, Rao BC. A Study Protocol of a Prospective, Open-label, Single-arm, Clinical Trial to Evaluate the Efficacy of Classical Ayurveda Medicines in the Management of Vicharchika (Atopic Eczema). J Res Ayurvedic Sci 2019; 3 (1):27-33.

DOI: 10.5005/jras-10064-0070

License: CC BY-NC 4.0

Published Online: 00-03-2019

Copyright Statement:  Copyright © 2019; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Background: In Ayurveda, Vicharchika (atopic eczema, AE) has been discussed under the heading of Kshudra kustha. It is a variety of inflammatory skin disorders diagnosed as a chronic, widespread, noninfective inflammatory condition that causes severe pruritus, erythema with variable degree of exudates and scaling, which can impact at any age. The etiology of AE is complex and not fully understood. Although the traditional Ayurveda medicine is used as an alternative therapy for AE, available evidence relating to its effectiveness and mechanism are not fully implicit. Hence, a protocol of a prospective, multicenter, single-arm, open-label clinical trial using traditional Ayurveda medicine to investigate the effectiveness, mechanism, and safety for patients with Vicharchika (eczema) is being reported. Materials and methods: This is a multicenter, single-arm, open-label clinical trial to evaluate the safety and efficacy of traditional Ayurveda formulations Panchatikta Ghrita and Nalpamaradi Taila in the management of Vicharchika (eczema). A total of 120 patients with Vicharchika (eczema) will be selected based on the inclusion and exclusion criteria. All the patients will be provided with classical Ayurvedic formulation, i.e., Panchatikta Ghrita 6 g orally twice daily before food and oil Nalpamaradi Taila 20 mL twice daily externally on the affected skin. Each participant will undergo a 12-week treatment period and a follow-up after 4 weeks. A total of seven visits will be scheduled for each participant: 1 visit each in week 0, week 2, week 4, week 6, week 8, week 10, and week 12. The primary outcome will be measured by the assessment of change in eczema area severity index (EASI) score before and after the recommended therapy. The secondary outcomes will be measured by—changes in clinical sign and symptoms per the Ayurvedic classics; changes in patient-oriented eczema measure (POEM) and changes in dermatology life quality index (DLQI) questionnaire. Therapeutic mechanism outcomes, safety outcomes, and end point outcomes will also be assessed. Discussion: Protocol was designed with projected outcome as better clinical deliverables and safety profile in Vicharchika patients and reduced relapse rate of disease during post treatment period. If found effective, the selected drug will be listed in the management protocol of Vicharchika at clinical practice level in terms of better efficacy, safety, and cost-effective treatment. The selected drug may lead to a step ahead of better understanding and management of additional skin disorders. Trial registration: Trial has been registered under clinical trials registry-India (CTRI); the registration number for this trial is CTRI/2019/12/022236.


PDF Share
  1. Buxton PK. Eczema and dermatitis. ABC of Dermatology. 4th ed., London: BMJ Publishing Group Ltd, BMA House, Tavistock Square; 2003. p. 17.
  2. Schmitt J, Apfelbacher CJ, Flohr C. Eczema. BMJ Clin Evid 2011;2011:1716.
  3. Lee JH, Son SW, Cho SH. A comprehensive review of the treatment of atopic eczema. Allergy Asthma Immunol Res 2016;8(3):181–190. DOI: 10.4168/aair.2016.8.3.181.
  4. Hegde P, Hemanth DT, Emmi SV, et al. A case discussion on eczema. Int J Ayurveda Res 2010;1(4):268–270. DOI: 10.4103/0974-7788. 76792.
  5. Hanifin JM, Rajka G. Disgnostic features of atopic dermatitis. Acta Derm Venereol Suppl 1980;92:44–47. DOI: 10.2340/00015555924447.
  6. Leshem YA, Hajar T, Hanifin JM, et al. What the eczema area and severity index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol 2015;172(5):1353–1357. DOI: 10.1111/bjd.13662.
  7. Charman CR, Venn AJ, Ravenscroft JC, et al. Translating patient-oriented eczema measure (POEM) scores into clinical practice by suggesting severity strata derived using anchor-based methods. Br J Dermatol 2013;169(6):1326–1332. DOI: 10.1111/bjd.12590.
  8. Finlay AY, Khan GK. Dermatology life quality index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19(3):210–216. DOI: 10.1111/j.1365-2230.1994.tb01167.x.
  9. Kaviraj Ambikadattshastri, ed. Sushruta samhita - Nidanasthana. 14th ed. Verse no. -5/5,8. Varanasi: Chaukambha Publications; 2010. pp. 247–248.
  10. Nath R, Mandal SK, Mahajon B. Rational diagnostic advance of Kushtha (integumentary diseases) by a preliminary arbitrary grading system based on Ayurveda fundamental principles. J Sci Innov Res 2019;8(2):37–45.
  11. Williams HC, Strachan DP. The natural history of childhood eczema: observations from the British 1958 birth cohort study. Br J Dermatol 1998;139(5):834–839. DOI: 10.1046/j.1365-2133.1998.02509.x.
  12. Anonymous. The Ayurvedic formulary of India (AFI) (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part I. 2nd ed., Delhi: The Controller of Publications; 2003. pp. 90–91.
  13. Anonymous. The Ayurvedic Pharmacopoeia of India, (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part II. 1st ed., vol. I, Delhi: The Controller of Publications; 2011. pp. 80–81.
  14. Anonymous. The Ayurvedic formulary of India (AFI) (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part I. 2nd ed., Delhi: The Controller of Publications; 2003. pp. 138–139.
  15. Anonymous. The Ayurvedic Pharmacopoeia of India, (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part II. 1st ed., vol. I, Delhi: The Controller of Publications; 2011. pp. 88–89.
PDF Share