| CTRI Number |
CTRI/2021/04/033014 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Open label clinical trial] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
result of vitimelin tablet and vitimelin oil in vitiligo |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy and safety of vitimelin tablet and vitimelin oil in vitiligo w.s.r. to shwitra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopal Krishan Dhakar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of kaumarbhritya, National Institute of Ayurveda, Jaipur(Raj.)
Dr Gopal Krishan Dhakar
quarter no. C-129, gole market jawahar nagar, jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8989844044 |
| Fax |
|
| Email |
krishna.gopi132@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Nagar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of kaumarbhritya, National Institute of Ayurveda, Jaipur(Raj.)
725, block 9 Vrinda garden, Jagatpura, Jaipur (raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Kumar Ojha |
| Designation |
associate professor & HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of kaumarbhritya, National Institute of Ayurveda, Jaipur(Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrVasishths Ayuremedies |
| Address |
A-3, Phase 2, Road 9 Gallops Industrial Park, Vasna-Chacharwadi, Ta. Sanand, Ahmedabad, Gujrat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gopal Krishan Dhakar |
National Institute of Ayurveda, Jaipur |
Madhav Vilas Palace, Amer road Jaipur (Rajasthan) 302002
Jaipur
RAJASTHAN |
8989844044
krishna.gopi132@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: Shwitra, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Vitimelin Tablet and Vitimelin oil |
Oral - Vitimelin Tablet 1 tablet TID (500 mg each),
Local application - Vitimelin oil- Two times on patches / affected area, after 10 min. of application sunlight / UVA lamp exposed on affected area for 20 min.
duration- 3 month |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1-Children of either gender aged group between 10 - 16 years.
2- Children having classical sign and symptom and diagnosed as vitiligo / Shwitra.
3- Patient should be capable of obeying the instruction related to course of therapy. |
|
| ExclusionCriteria |
| Details |
1- Children below 10 years and above 16 years of age.
2- Patches more than 30% of the body, Broad continuous irregular patches.
3- Children with albinism will be excluded.
4- White anesthetic spot which are characterized of leprosy.
5- Patches in genital area and only lip area are excluded from the study.
6- Patient not fulfilling the inclusion criteria.
7- Patient suffering from any other known systemic and chronic disease / Autoimmune
disorder.
8- Patient not willing to give consent for participation in the Research study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in VASI score. |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of trial drug (Vitimelin Tablet and Vitimelin Oil). |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2021 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vitiligo is an acquired, chronic, pigmentary disorder characterized by the progressive loss of cutaneous melanocytes and abnormality in their normal function resulting in hypo pigmented skin area which progressively becomes amelanotic. The cause is unknown but might be involve genetic factor, autoimmunity, neurological factors, toxic metabolites and lack of melanocyte growth factor. It can also affect the eye, the inside of mouth and hair. The condition is photosensitive. It is hard to predict whether the patches will spread and by how much. The spread might take week or the patches might remain stable for month or years. According to Ayurveda in Charaka Samhita, Shvitra is enumerated as “Raktaj vicar. Bhrajak pitta which is responsible for skin colour, gets vitiatedin this disease. The combinations of Rakt and pitta dosha are mentioned asashayaashrayabhav.Shvitra is considered as aType of Kilas and Tridoshaj vyadhi. Most of Ayurveda Authors use Shvitra and Kilasa as synonyms. |