MedPath

Homeopathic treatment of white patch

Phase 3
Completed
Conditions
Vitiligo,
Registration Number
CTRI/2018/10/016160
Lead Sponsor
National Institute of Homoeopathy
Brief Summary

Vitiligo  is an  acquired  de-pigmentation  disorder characterized  by  loss of  melanocytes  from epidermis. Worldwide  prevalence of  Vitiligo  ranges is 0.4  and  2% and in India the relative  prevalence varied  between  0.46 and  8.8%. Studies reveals apositive role of homoeopathy in Vitiligo  where   varying   degrees  of   repigmentation   was reported. In this prospective, doubleblind, randomised, placebo controlled, parallel arm trial at National Instituteof Homoeopathy, 60 patients suffering from vitiligo will be randomised in 1:1ratio into either individualised homeopathic medicines in 50 millesimal scaleor identical placebo. VASI will be used as the primary outcome measure and VitiQoLquestionnaire and DLQI as secondary outcome measures, measured at baseline, 3rdmonth and 6th month. At the end of 6 months, comparative analysiswill be carried out to detect group differences, if any. Results will bepublished in scientific journals.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Suffering from Vitiligo for at least last 3 months 2.
  • Patients of both sexes 3.
  • Age between 18-65 years 4.
  • Literate; able to read English and/or Bengali 5.
  • Patients who have not taken any treatment since last 2 weeks for Vitiligo.
Exclusion Criteria
  • Patients who are too sick for consultation 2.
  • Unwilling to take part and not giving consent to join the study 3.
  • Unable to read patient information sheet 4.
  • Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure 5.
  • Pregnancy and lactation 6.
  • Substance abuse and/or dependence 7.
  • Self-reported immune-compromised state 8.
  • Undergoing homoeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vitiligo area scoring index (VASI) evaluateing disease extent and severityAt baseline, 3rd month and 6th month
Secondary Outcome Measures
NameTimeMethod
Vitiligo Specific Health Related Quality of Life Instrument (VitiQOL)At baseline, 3rd month and 6th month
Dermatological Life Quality Index (DLQI) questionnaireAt baseline, 3rd month and 6th month

Trial Locations

Locations (1)

National Institute of Homoeopathy

🇮🇳

Kolkata, WEST BENGAL, India

National Institute of Homoeopathy
🇮🇳Kolkata, WEST BENGAL, India
K Avaranjika
Principal investigator
8778968586
kannanavaranjika@gmail.com

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