| CTRI Number |
CTRI/2016/03/006759 [Registered on: 22/03/2016] Trial Registered Prospectively |
| Last Modified On: |
18/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Karpanpatru Taila Roll on, prepared with sesame oil and coconut oil on Vitiligo |
|
Scientific Title of Study
|
Pharmaceutical standardization of Karpanapatru Taila Roll-on prepared with Tila Taila and Narikela Taila and their comparative efficacy in the management of Shvitra (Vitiligo) |
| Trial Acronym |
KPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahara Shrestha |
| Designation |
MD Scholar |
| Affiliation |
Institute for Post Graduate teaching and Research in Ayurveda |
| Address |
Department of Rasashastra and Bhaishajyakalpana
Institute for Post Graduate teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Department of Rasashastra and Bhaishajyakalpana
Institute for Post Graduate teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7048653655 |
| Fax |
|
| Email |
saharestha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant bedarkar |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Post Graduate teaching and Research in Ayurveda |
| Address |
Department of Rasashastra and Bhaishajyakalpana
Institute for Post Graduate teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Department of Rasashastra and Bhaishajyakalpana
Institute for Post Graduate teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8128217370 |
| Fax |
|
| Email |
drprashantbedarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant bedarkar |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Post Graduate teaching and Research in Ayurveda |
| Address |
Department of Rasashastra and Bhaishajyakalpana
Institute for Post Graduate teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Department of Rasashastra and Bhaishajyakalpana
Institute for Post Graduate teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8128217370 |
| Fax |
|
| Email |
drprashantbedarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA
Jamnagar
361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate teaching and Research in Ayurveda |
| Address |
Gujarat Ayurved University
Jamnagar, Gujarat, 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sahara Shrestha |
Institute for Post Graduate teaching and Research in Ayurveda |
Room no.13 Department of Rasshastra and Bhaishjya kalpana Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT |
7048653655
saharestha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, Shvitra (Vitiligo), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karpanpatru taila Roll on prepared from tila taila |
external medicament in sufficient quantity for 2 months |
| Comparator Agent |
Karpanpatru taila Roll on prepared with Narikela taila |
External medicament in sufficient quantity for two months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Shvitra (vitiligo).
Patients having Sadhya Lakshana of Shvitra.
Patients having ages of 16 to 60 years.
Patients with chronicity of less than 10 years.
Wood’s lamp test positive.
|
|
| ExclusionCriteria |
| Details |
Age < 16 and > 60 years
Chronicity more than 10 years.
Serious cardiac, renal, hepatic diseases, major illness like IDDM, NIDDM, patches due to burning, chemical, any other serious systemic illness.
Gravid and lactating women.
Ekanga (Segmental Vitiligo)
Patches with Raktaroma (reddish hair) & Samsakta (coalescent).
Hypersensitive and Photosensitive patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Test drug will be effective in reducing patches of vitiligo |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It will improve quality of life and complexion of body |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/03/2016 |
| Date of Study Completion (India) |
15/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Shrestha S, Bedarkar P, Patgiri B, Shukla VJ, Prajapati PK. Standard Manufacturing Procedure and Quality Control of Karpanpatru Roll-on Prepared with Coconut Oil. J Ayu Med Sci 2017;2(3):225-9. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Vitiligo (leukoderma) is a pigmentation disorder with complex causes. Depigmented patches appear on the skin, hair, mucous membranes and the retina. Ayurvedic medicine has been widely used in Indian subcontinent since ages. In the treatment of Shvitra (vitiligo), single drugs like Bakuchi (Psoralea corylifolia Linn.), Khadira (Acacia catechu Wild.), Kakodumbara (Ficus hispida Linn.), Apamarga (Achyranthes aspera Linn.) etc., and compound formulations like Shashilekha Vati, Shvitrari Rasa, Shvitrahara Varti, Gomutrasava etc., are successfully used. Karpanpatru Taila is one among such compound formulation mentioned in Siddha Pharmacopoeia and has been safely used to treat Shvitra since many years. In previous study, Karpanpatru Taila was prepared by using three different media keeping same base as Sarshapa Taila. No clinical work was carried out to evaluate role of different Taila as base by using roll-on. Considering this, this study is undertaken to evaluate role of different Taila and their clinical efficacy of Karpanpatru Taila roll-on prepared by Tila Taila and Narikela Taila in Shvitra. |