| CTRI Number |
CTRI/2023/10/058389 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Add on effect of Savarnakar lepa with Shashilekha vati in shwitra vyadhi (Leucoderma or vitiligo) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to compare the add on effect of Savarnakar lepa with shashilekha vati in shwitra vyadhi(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 |
Dr Mayuri Chavan |
| Designation |
PhD Scholar |
| Affiliation |
Seth Tarachand Ayurved Hospital, Kayachikitsa department opd no 5 Rastha peth pune |
| Address |
Rashtriya shikshan Mandals,centre for post Graduate studies and Reasearch in Ayurved of Tilak Ayurved Mahavidyalaya.Kaychikitsa department583/2 rastha peth pune
Rashtriya shikshan Mandals centre forpost Graduate studies and Research in Ayurved of Tilak Ayurved Mahavidyalaya.Kaychikitsa department 583/2 rastha peth pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7057081509 |
| Fax |
|
| Email |
drmayurichavan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deshpande S v |
| Designation |
HOD and Professor |
| Affiliation |
Seth Tarachand Ayurved Hospital, Kayachikitsa department opd no 5 Rastha peth pune |
| Address |
Rashtriya Shikshan Mandals, Centre for Post Graduate studies and Research in Ayurved.Tilak Ayurved Mahavidyalaya. Kayachikitsa department 583/2 Rastha Peth Pune
Rashtriya Shikshan Mandals, Centre for Post Graduate studies and Research in Ayurved.Tilak Ayurved Mahavidyalaya. Kayachikitsa department 583/2 Rastha Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deshpande S v |
| Designation |
HOD and Professor |
| Affiliation |
Seth Tarachand Ayurved Hospital, Kayachikitsa department opd no 5 Rastha peth pune |
| Address |
Rashtriya Shikshan Mandals Centre for Post Graduate Studies and Research in Ayurved of Tilak Ayurved Mahavidyalaya Kayachikitsa department 583/2 Rastha peth pune
Rashtriya Shikshan Mandals Centre for Post Graduate Studies and Research in Ayurved of Tilak Ayurved Mahavidyalaya Kayachikitsa department 583/2 Rastha peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rashtriya shikshan Mandals Centre for Post Graduate Studies and Research in Ayurved of Tilak Ayurved Mahavidyalaya Kayachikitsa Department 583/2 Rashtha peth pune. |
|
|
Primary Sponsor
|
| Name |
Dr Mayuri Chavan |
| Address |
Rashtriya shikshan mandals Centre for Post Graduate Studies and Reasearch in Ayurved of Tilak Ayurved Mahavidyalaya Kayachikitsa Department 583/2 Rastha peth pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Mayuri Chavan |
Tilak Ayurved Mahavidyalaya pune |
Rashtriya shikshan Mandals Centre for Post Graduate Studies and Research in Ayurved of Tilak Ayurved Mahavidyalaya Kayachikitsa Department opd number 05 583/2 Rastha peth pune
Pune
MAHARASHTRA |
7057081509
drmayurichavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional ethical committee Tilak Ayurved mahavidyalaya pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SHWITRA VYADHI(VITILIGO) |
| Patients |
, , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Savarnakar lepa and shashilekha vati, Reference: Ashtang Hriday chikitsa 20/13 and Yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -Shashilekha Vati 250 mg apanau with madhu | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shashilekha vati, Reference: Yogratnakar Kushtha chikitsa 218 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Prediagnosed patients of shwitra (vitiligo).
patients having signs and sympyoms of shwitra.
patients of any sex, religion and socio-Economic status. |
|
| ExclusionCriteria |
| Details |
Shwitra or vitiligo due to Burn.
preganant and Lactating mothers.
Patients having severe other chronic diseases like Maliganacy, Target organ damage, any genetic syndrome,heart diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome of treament is repigmentation will start in the depigmentary white lesions |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Woods Lamp Examination
Before & after Photographs |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/11/2023 |
| 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="2"
Months="6"
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
|
In Ancient Ayurved , Vitiation of the Bhrajak Pitta with Vata, Kapha Dosha and Rakta,Mansa,Meda dhatu get resulted into Twak Vaivarnya i.e. Shwet Varna of the skin. In Modern sciences, Destruction of functional melanocyttes from the epidermis of skin, often overlying hair & mucous Membrane which results into patchy loss of pigmentation & discoloration of skin termed as leucoderma or vitiligo. it is cosmetically distrubing disease, which has major impact on quality of life & psychologically devastating effects on affected individuals. In Ayurveda lots of kalpas & Lepas are described for the treatment of shwitra chikitsa in classic samhitas & texts. Here Savarnakar lepa & shashilekha vati (Astang Hriday chi 20/13 & Yogratnakar Kushta chikitsa 218) are taken to study under the hypothesis H1 that Savarnakar lepa with shashilekha vati is more effective than shashilekha vati in the managment of shwitra. and H0 that Savarnakar lepa with shashilekha vati is as effective as shashilekha vati in the mangement of shwitra. presently selection of the study topic to compare the add on effect of the savarnakar lepa with shshilekha vati with different route of administration to improve treatment modalities. |