| CTRI Number |
CTRI/2023/07/054761 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to treat hyperpigmentation by using Chinchadi lepa |
|
Scientific Title of Study
|
A Randomized open labelled controlled clinical study to evaluate the efficacy of Chinchadi lepa in the management of Vyanga with special reference to Melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavana H N |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
#114,1ST CROSS,NEAR NARAYANA E TECHNO SCHOOL,BALAJI LAYOUT, MALLATHAHALLI BANGALORE-560056
Department of Dravyaguna,
Sri Sri College Of Ayurvedic Science and Research, Udayapura post, Bengaluru- 560082
Bangalore
KARNATAKA
560056
India |
| Phone |
09108129795 |
| Fax |
|
| Email |
bhavanaudupa948@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAHESH C D |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Bengaluru |
| Address |
Sri Sri College Of Ayurvedic Science and Research Hospital, Department of Dravyaguna OPD, Room no 105,21st km, Kanakapura road, Udayapura post, Bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
9986303884 |
| Fax |
|
| Email |
drmaheshcd@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana H N |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
#114,1ST CROSS,NEAR NARAYANA E TECHNO SCHOOL,BALAJI LAYOUT, MALLATHAHALLI BANGALORE-560056
Department of Dravyaguna,
Sri Sri College Of Ayurvedic Science and Research, Udayapura post, Bengaluru- 560082
KARNATAKA
560056
India |
| Phone |
09108129795 |
| Fax |
|
| Email |
bhavanaudupa948@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research |
|
|
Primary Sponsor
|
| Name |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, KANAKAPURA ROAD, UDAYAPURA POST, BENGALURU-560082. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavana H N |
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Bengaluru. |
Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengaluru, Karnataka 560082, Bengaluru
Bangalore
KARNATAKA |
9108129795
bhavanaudupa948@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chinchadi Lepa |
The subjects will be asked to wash the face and dry it completely with a clean cloth.
Chinchadi Lepa will be given and asked to apply quantity sufficient of lepa as thin layer over the affected area and massage it on outward and upward stroke until it is absorbed.
Duration- Once a day. |
| Comparator Agent |
Kunkumadi Lepa |
The subjects will be asked to wash the face and dry it completely with a clean cloth.
Kunkumadi Lepa will be given and asked to apply quantity suffient of Lepa as a thin layer over the affected area and massage it in outward and upward stroke until it is absorbed
Duration- Once a day |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of hyperpigmentation |
One year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complexion improvement |
One year |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized Parallel group open- labelled.controlled clinical study.| Features | Group A | Group B | | Sample size | 15 | 15 | | Intervention | Kunkumadi Lepa | Chinchadi Lepa | | Dosage | Quantity sufficient | Quantity sufficient | | Time of administration | Morning | Morning | | Trial Period | 30 days | 30 days | | Mode of administration | External application | External application | | Total Weight | 50g | 50g | | Assessment | 0th, 15th, 30th Day | 0th, 15th, 30th Day | | Drug free follow up | 45th day | 45th day |
|