| CTRI Number |
CTRI/2024/09/073884 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study on ayurveda drugs Bibhitakadi Kwatha & Avalgujadi Lepa in the treatment of skin disease |
|
Scientific Title of Study
|
A Clinical Study to Evaluate The Efficacy of Bibhitakadi Kwatha & Avalgujadi Lepa in The Management of Shwitra (Vitiligo) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Bhaskar |
| Designation |
PhD Scholar |
| Affiliation |
Madan Mohan Malviya govt ayurved college udaipur |
| Address |
Room no 6 post graduate institute of Ayurveda PG dept of kayachikitsa Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University ,Jodhpur
Udaipur
RAJASTHAN
342037
India |
| Phone |
7568338491 |
| Fax |
|
| Email |
ayushibhaskar18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indumati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya govt ayurved college Radaji circle Ambamata udaipur |
| Address |
PG dept of kayachikitsa Madan Mohan Malviya govt ayurved college Radaji circle Ambamata udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972210 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Bhaskar |
| Designation |
Assistant Professor |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan,jodhpur,pincode 342037 |
| Address |
Room no. 116 P.G. department of kayachikitsa postgraduate institute of Ayurveda Dr sarvepalli Radhakrishnan Rajasthan,jodhpur
Udaipur
RAJASTHAN
342037
India |
| Phone |
7568338491 |
| Fax |
|
| Email |
ayushibhaskar18@gmail.com |
|
|
Source of Monetary or Material Support
|
| postgraduate institute of Ayurveda,Dr.S.R.Rajasthan Ayurved University, Karwar Jodhpur India pincode 342037 |
|
|
Primary Sponsor
|
| Name |
Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved Univetrsity ,Jodhpur |
| Address |
Room no 116 post graduate institute of Ayurveda PG dept of kayachikitsa Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur,pin code 342037
|
| 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 Ayushi Bhaskar |
Sanjeevani Ayurved Hospital ,Post graduate institute of Ayuveda DSRRAU Jodhpur |
Room no 6 postgraduate Department of Kayachikitsa,postgraduate institute of Ayurveda, DSRRAU, Jodhpur
Jodhpur
RAJASTHAN |
7568338491
ayushibhaskar18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Madan Mohan Malviya Government Ayurved College ,Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhavprakash under the chapter of Kustha Rogadhikar madhyam khand chapter no 54 shlok 151 and 152, Procedure details: Apply with Gomutra Once a day)
(1) Medicine Name: AVALGUJADI LEPA,, Reference: Bhavprakash under the chapter of Kustha Rogadhikar madhyam khand chapter no 54 shlok 151 and 152, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Duration: 90 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BIBHITAKADI KWATHA, Reference: Bhaishajya Ratnavali under the chapter of KusthaRogadhikar chapter no 54 shloka no 73, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: BIBHITAKADI KWATHA,AVALGUJADI LEPA,, Reference: Bhaishajya Ratnavali under the chapter of KusthaRogadhikar chapter no 54 shloka no 73, Reference: Bhavprakash under the chapter of Kustha Rogadhikar madhyam khand chapter no 54 shlok 151 and 152, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -In this group there are two medicine which is going to be used nad there is no option in this format to add both medicine. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms of Shwitra Roga, specifically skin depigmentation (Twak Vaivarnya), will be selected for this study. This includes individuals exhibiting the classical signs and symptoms of Shwitra, regardless of sex, aged between 18 and 60 years. Participants must be willing to sign the consent form, take the prescribed medicine properly, adhere to dietary and lifestyle guidelines (Pathya - Apathya), and be cooperative in following all study instructions. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have severe skin disorders, chronic systemic diseases, sexually transmitted diseases, uncontrolled diabetes mellitus, blood-related disorders, or organ failure. Other exclusions include those on medication for the same illness, unwilling participants, patients with leprosy, albinism, pregnant or lactating women, patches from trauma, burns, or chemical exposure, long-term steroid or cytotoxic treatment, adverse reactions to treatment, and malignancy. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the clinical study evaluating the efficacy of Bibhitakadi Kwatha and Avalgujadi Lepa in the management of Shwitra (Vitiligo). |
Total study time 90 days
Follow up at every 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bibhitakadi Kwatha & Avalgujadi Lepa will provide a safe & effective treatment.
Improve the Quality of life & wellbeing
|
at every 15 days progress & efficacy will be assesed |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized, prospective, open-label, interventional comparative clinical trial. The trial consists of three groups: one will receive Bibhitakadi Kwatha ,the second group will receive Avalgujadi Lepa, and the third group will receive both Bibhitakadi Kwatha and Avalgujadi Lepa together. |