Homeopathic treatment of white patches on skin

Phase 3

Completed

Conditions: Vitiligo,

Registration Number: CTRI/2018/04/013446

Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary: Vitiligo is a common chronic skin depigmentationdisorder. It is due to stoppage of melanin formation by the melanocytes and presentsas asymptomatic depigmented macules anywhere on the body including mucousmembranes of lips and genitalia. In vitiligo, there is a marked reduction or evenabsence of melanocytes and melanin in the epidermis. It affects around 0.5%-1% of the world population. As high as 8.8% prevalence have been reported inIndia, where considerable stigma is attached to the disease. Vitiligo patches can appear anywhere on theskin, but commonly affected sites include the area around the orifices, thegenitals or any sun-exposed areas such as the face and hands. The hair andrarely, the eyes may also be affected. Fifty percent of cases appear before the age of20, with the disfigurement resulting in psychiatric morbidity in 16-35% ofthose affected. Depression, sleep disturbances, suicidal thoughts, suicidal attempts,difficulties in relationships, and avoidance of social situations have beenreported in individuals afflicted by vitiligo before adulthood. In India, in particular, it ranges from 6.25-18%.Some studies reveal it as high as 40%. In 19th century, practitioners acknowledged limitations fortreatment of this condition and suggested Sulphide of Arsenicum to lessen thepatch. The homoeopathic literature suggest a number of medicines for the conditions. In a recent review, 11 research papers related to homoeopathy on vitiligowere identified. The investigators also identified a recentlypublished case series revealing promising role of homoeopathy in treatment ofvitiligo. Under such circumstances, the authors considerit very important to undertake a pragmatic trial with adequate methodologicalrigor. In this prospective, open, randomized, three parallelarms, pragmatic trial, 60 patients suffering from vitiligo will be randomized to either individualized homeopathic medicines (IH; n=20), or Psoralea corylifolia mother tincture external application (PC; n=20), or both (IH + PC; n=20). Outcomes will be measured in terms of VASI, VitiQoL, and DLQI, measured at baseline, after 3 months, and after 6 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age 18-65 years 2.
Both sexes 3.
Literate; able to read English or Bengali 4.
Suffering from vitiligo for at least last 3 months.

Exclusion Criteria

Patients who are too sick for consultation 2.
Patients not giving consent to take part 3.
Diagnosed cases of unstable psychiatric illness or other systemic disease or infection affecting quality of life or any vital organ failure 4.
Pregnancy and lactation 5.
Self-reported immune-compromised state 6.
Substance abuse and/or dependence 7.
Undergoing homeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitiligo Area Scoring Index (VASI)	Baseline, after 3 months and after 6 months

Secondary Outcome Measures

Name	Time	Method
Vitiligo Quality of Life Questionnaire (VitiQoL)	Baseline, after 3 months and after 6 months
Dermatological Life Quality Index (DLQI) questionnaire	Baseline, after 3 months and after 6 months

Trial Locations

Locations (1): National Institute of Homoeopathy, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy, Govt. of India
🇮🇳Kolkata, WEST BENGAL, India
Abhijit Chattopadhyay
Principal investigator
7003547446
drac.nih@gmail.com