A clinical study to treat hyperpigmentation by using Chinchadi lepa

Phase 3

Not yet recruiting

• Conditions: Chloasma,

• Registration Number: CTRI/2023/07/054761
• Lead Sponsor: SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH

Brief Summary

A Randomized Parallel group open- labelled.controlled clinical study.

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| --- | --- | --- |

| FeaturesGroup AGroup B

| Sample size 1515

| InterventionKunkumadi LepaChinchadi Lepa

| DosageQuantity sufficientQuantity sufficient

| Time of administrationMorningMorning

| Trial Period30 days30 days

| Mode of administrationExternal applicationExternal application

| Total Weight50g50g

| Assessment0th, 15th, 30th Day0th, 15th, 30th Day

| Drug free follow up45th day45th day

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-07
• Study Start: 2023-07-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• Subjects of either gender with the age group between 21-60 years.
• Subjects fulfilling the diagnostic criteria of Vyanga with special reference to Melasma will be randomly selected, irrespective of their religion, occupation and socio-economic status.

Exclusion Criteria

• Female on oral contraceptive pills, pregnant women and lactating women.
• Subjects who are on any hormonal therapy.
• Subjects who are known hyperpigmentation since birth.
• Subjects who are known inflammatory pigmentation.
• Subjects who are known malignant melanoma.
• Any other condition interfering with the course of the treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of hyperpigmentation	One year.

Secondary Outcome Measures

Name	Time	Method
Complexion improvement	One year

Trial Locations

Locations (1)

Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Bengaluru.; 🇮🇳 Bangalore, KARNATAKA, India

Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Bengaluru.

🇮🇳Bangalore, KARNATAKA, India

Dr Bhavana H N

Principal investigator

9108129795

bhavanaudupa948@gmail.com