| CTRI Number |
CTRI/2021/05/033829 [Registered on: 27/05/2021] Trial Registered Prospectively |
| Last Modified On: |
25/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical Study on local application of Baladi lepa to treat hyperpigmentation of skin in sun exposed areas |
|
Scientific Title of Study
|
A clinical study of Sushrutokta Baladi lepa efficacy in Vyanga chikitsa with special reference to twaksharir |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjali |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna govt ayurvedic college and Hospital |
| Address |
PG DEPT Of Rachana Sharir,Shri krishna govt ayurvedic college and hospital
Kurukshetra
HARYANA
136118
India |
| Phone |
8222903236 |
| Fax |
|
| Email |
preetiohlan1694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjali |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna govt ayurvedic college and Hospital |
| Address |
PG DEPT Of Rachana Sharir,Shri krishna govt ayurvedic college and hospital
Kurukshetra
HARYANA
136118
India |
| Phone |
8222903236 |
| Fax |
|
| Email |
preetiohlan1694@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Vats |
| Designation |
Professor and HOD |
| Affiliation |
Shri krishna govt ayurvedic college and hospital |
| Address |
PG Dept of Rachana Sharir,Shri Krishna Govt Ayurvedic College and Hospital
Kurukshetra
HARYANA
136118
India |
| Phone |
9416291617 |
| Fax |
|
| Email |
drsatishvats@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri krishna govt ayurvedic college and hospital,kurukshetra,,Haryana,136118 |
|
|
Primary Sponsor
|
| Name |
Shri krishna govt ayurvedic college |
| Address |
PG Dept of Rachana Sharir,Shri krishna govt ayurvedic college and hospital,kurukshetra, Haryana,136118 |
| Type of Sponsor |
Government 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 Ranjali |
Shri krishna govt ayurvedic college and hospital |
Room number 18,Tutorial room,PG Dept of Rachana Sharir,Shri krishna govt ayurvedic college and hospital,kurukshetra, Haryana,136118
Kurukshetra
HARYANA |
8222903236
preetiohlan1694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local application of BALADI LEPA |
Written consent should be taken.Baladi lepa should be prepared by mixing fine powder of bala,atibala,mulaithi and hridra using water as media.It should be prepared fresh for every use and kept for 20 minutes after each application.
Duration of trial will be of 60 days and total number of visits will be 6 visits. One visit in every 15 days. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Vyanga rog irrespective of sex, religion and occupation |
|
| ExclusionCriteria |
| Details |
Drug allergy,patient taking hormonal pills,pregnancy,Hb less than 8gm/dl,hyperpigmentation due to systemic diseases,hyperpigmentation since birth or due to malignancy,below 16 years or above 60 years of age |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in sign and symptoms of Hyperpigmentation of skin |
Two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acquired hyperpigmentation disorder of skin is common problem now a days. It causes negative impact on patient’s emotional well being and social life .Melasma or Vyanga rog causes chronic hyperpigmentation of skin on sun exposed areas, particularly on face. The treatment modalities for it remains unsatisfactory and shows remission from time to time. Pigment targeting laser therapy also remain challenging for the patients. External application plays a major role in skin disorders. I hereby evaluate the efficacy of Baladi Lepa in Vyanga rog chikitsa mentioned by Acharya Sushruta as it is safe and cost effective for the patients |