| CTRI Number |
CTRI/2021/09/036825 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
efficacy between Gunjaphaladi Lepa and Avalgujbeejadi Lepa in Vitiligo |
|
Scientific Title of Study
|
A Comparative Clinical Study of Gunjaphaladi Lepa and Avalgujbeejadi Lepa in the management of Kilaasa (Vitiligo) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Kumar |
| Designation |
M.D (Ay.) Scholar |
| Affiliation |
Government Ayurvedic College, Patna |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka
Government Ayurvedic College
Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
9709834134 |
| Fax |
|
| Email |
ayushpk5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Kumar Singh |
| Designation |
Professor & HOD |
| Affiliation |
Government Ayurvedic College, Patna |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka
Government Ayurvedic College
Kadamkuan
Patna
Patna
BIHAR
800003
India |
| Phone |
9199373517 |
| Fax |
|
| Email |
jai.kumar1966@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jai Kumar Singh |
| Designation |
Professor & HOD |
| Affiliation |
Government Ayurvedic College, Patna |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka
Government Ayurvedic College
Kadamkuan
Patna
BIHAR
800003
India |
| Phone |
9199373517 |
| Fax |
|
| Email |
jai.kumar1966@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Research unit-OPD No-10 Government Ayurvedic College & Hospital, Kadamkuan, Patna
Pin- 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayuvedic College Patna |
| Address |
Government Ayurvedic College & Hospital, Kadamkuan
Patna
Pin-800003 |
| 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 Praveen Kumar |
Government Ayurvedic College & Hospital, Patna |
Room No-10
Research unit
Government Ayurvedic College and Hospital
Kadamkuan
Patna- 800003
Patna
BIHAR |
9709834134
ayushpk5@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Government Ayurvedic College, Patna- 800003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: Kilaasa , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gunjaphaladi Lepa, Reference: Bhaishajya Ratnawali Kustha Roga/49, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Avalgujbeejadi Lepa, Reference: Chakradutta Kustha Chikitsa/69, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-as per classical sign and symptoms described in ayurvedic texts and modern literature.
- Prediagnosed patient of Kilaasa(vitiligo) |
|
| ExclusionCriteria |
| Details |
-Patients below 12 yrs. and above 60 yrs.
-Chronicity of kilaasa more than 5 yrs.
-Patients associated with diabetes, AIDS, Hep-B, leukemia
-Pregnant women/lactating women
-white anesthetic spots which are character of leprosy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The assessment will be based on the color, size,VETF, VIDA score, margins of the lesion and % of area involvement of the white patches. |
Patients will be followed up after 15 days up to 3 months of trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvemeent in the quality of kilaasa(vitiligo) |
Evaluation will be done after 90 days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
28/05/2022 |
| 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)
|
Not Applicable |
| 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
|
In this study, 60 clinically diagnosed and confirmed patients of kilaasa (vitiligo) will be divided into 2 groups of 30 patients each. Group I will be given Gunjaphaldi lepa and Group II will be given Avalgujbeejadi lepa. The data will be collected and assessed by different scales of measurement. 6 evaluation will be done by follow up after every 15 days The patients will be evaluated on the basis of subjective and objective parameter to assess the efficacy of the intervention.
|