| CTRI Number |
CTRI/2012/06/002729 [Registered on: 15/06/2012] Trial Registered Retrospectively |
| Last Modified On: |
25/09/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Concept of Skin Colour and to clinically evaluate the efficacy of an Ayurvedic formulation in Melasma |
|
Scientific Title of Study
|
A Study on the concept of Varnya vis-a-vis clinical evaluation of Varnya Gana lepa in Vyanga |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PallaviG |
| Designation |
Final yr M.D Scholar |
| Affiliation |
Government Ayurveda Medical College Mysore |
| Address |
#751 12th cross 2nd main 3rd stage Gokulam Mysore
Government Ayurveda Medical College Sayyaji rao road
Mysore
Mysore
KARNATAKA
570021
India |
| Phone |
9844616528 |
| Fax |
|
| Email |
drgpallavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DLBalakrishna |
| Designation |
Professor & Head of the Department |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bangalore |
| Address |
Professor & Head of the Department, Department of Panchakarma, Government Ayurveda Medical College Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9449042330 |
| Fax |
|
| Email |
drdlbalakrishna52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PallaviG |
| Designation |
Final yr M.D Scholar |
| Affiliation |
Government Ayurveda Medical College Mysore |
| Address |
#751 12th cross 2nd main 3rd stage Gokulam Mysore
Government Ayurveda Medical College Sayyaji rao road
Mysore
Mysore
KARNATAKA
570021
India |
| Phone |
9844616528 |
| Fax |
|
| Email |
drgpallavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda Medical College and Hospital , Sayyaji Rao road, Mysore-570001 |
|
|
Primary Sponsor
|
| Name |
PallaviG |
| Address |
#751 12th cross 2nd main 3rd stage Gokulam Mysore-570021 |
| Type of Sponsor |
Other [Personal] |
|
|
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 |
| Pallavi |
Mysore |
Department of Post Graduate Studies in Ayurveda Siddhanta, Government Ayurveda Medical College and Hospital , Sayyaji rao road , Mysore-570001
Mysore
KARNATAKA |
09844616528
drgpallavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Government Ayurveda Medical College MysoreSri Bhaskar A.M. Smt . Sindhu Suresh Dr.Lancy D’Souza. Dr.Aruna. Dr.H.M.Chandramouli. Dr.Prameela, Dr.Shakuntala.G.N Dr.S.G.Mangalgi.D Dr.Ashok D.Satpute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Melasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External application-Varnya Gana lepa |
It is a fine powder , a mixture of 10 raw drugs, Chandana, tunga, padmaka, ushira, madhuka, manjishtha, sariva, payasya, sita, lata. The powder is mixed with sufficient amount of luke warm water to make it into a paste and is then applied on affected areas.
Dose-Quantity sufficient depending on the size of the lesion
Frequency-Twice daily( Morning and Evening)
Duration-15days
Route of Administration-External application |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with clinical signs of the disease Vyanga as per ayurvedic classics will be included.
2.Patients between age group of 16-60 years will be selected for the study.
3Patients irrespective of sex, religion, occupation, and chronicity will be selected for the study.
|
|
| ExclusionCriteria |
| Details |
1.Hyperpigmentation caused due to any systematic disease like Addisons disease, Cushings syndrome and SLE.
2.Hyperpigmentation since birth like Neavus
3.Hyperpigmentation caused by tumor like malignant melanoma.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Darkness of the lesion
Area of involvement
Homogeneity of the lesion |
15days & 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Skin /Lesion Colour
Texture (Dry/Oily)
Skin lustre
Number of Lesions
Size of Lesions
|
15days & 30 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/12/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The clinical component of the study was a clinical study consisting of sample size of 35 patients of Vyanga (Melasma). All the patients were assigned to a single group .Different parameters were used as assessment criterias . They were Skin colour, Lesion colour, Skin texture-dryness/oilyness, Skin lustre, Number and Size of the lesions, Darkness, Area and Homogeneity of lesion, Itching, Burning sensation, MASI Score. Varnya Gana lepa was administered for 15 days followed by same duration of follow up. The different parameters of the study were observed and recorded before treatment, after treatment and after the follow-up. The results were analyzed statistically based on the scores obtained from MASI and other assessment parameters for statistical significance. There was statistically highly significant improvement in the MASI Scores but in overall assessment 64.5% patients had mild improvement. Clinical improvement was more evident in Darkness parameter when compared to other parameters. |