| CTRI Number |
CTRI/2023/09/057189 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Ayurvedic Medicine In Shwitra Kustha W.s.r.Vitiligo |
|
Scientific Title of Study
|
Randomized Controlled Trial Of Navayasarasayan Churna And Somaraji Churna In The Management Of ShwitraKustha With Respect To Vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Gorakh Mane |
| Designation |
PhD Scholar |
| Affiliation |
Siddhakala Ayuved College Sangamner |
| Address |
Near Divekar Gas Agency Maldad Road,Sangamner,Dist -Ahmednagar
Near Divekar Gas Agency Maldad Road,Sangamner,Dist -Ahmednagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
09730657903 |
| Fax |
|
| Email |
drsgmane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhagavat T Shinde |
| Designation |
Professor |
| Affiliation |
PMTs Ayurved Mahavidayalaya,Shevgaon |
| Address |
Department Of Kayachikitsa,PMT Ayurved College Shevgaon ,Ahmednagar,Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9922709070 |
| Fax |
|
| Email |
sbhagwat.2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhagavat T Shinde |
| Designation |
Professor |
| Affiliation |
PMTs Ayurved Mahavidayalaya,Shevgaon |
| Address |
Department Of Kayachikitsa,PMT Ayurved College Shevgaon ,Ahmednagar,Maharashtra
Same As Above
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9922709070 |
| Fax |
|
| Email |
sbhagwat.2007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kayachikitsa Siddhakala Ayurved College,Sangamner |
|
|
Primary Sponsor
|
| Name |
Sandeep Gorakh Mane |
| Address |
siddhakala Ayurved college Sangamner |
| 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 |
| Sandeep Gorakh Mane |
Siddhakala Ayurved College Sangamner |
Department Of Kayachikitsa Opd.No.1 Sangamner
Ahmadnagar
MAHARASHTRA |
09730657903
drsgmane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethical comitee Shevgaon |
Approved |
| Siddhakala ayurved Ethical comitee sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: shwitra, (2) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navayasa Rasayan Churna, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Somaraji Chrna, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with SadhyaLakshana of Shwitra.
2) Patients having lesions at axillary, inguinal and buttock region.
3) Patients in the age group of 18 to 60 years.
4) Patches up to 1 year old.
5) Patients of irrespective of sex, religion and socioeconomic status.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1To Study Kusthgna Effect Of NavayasaRasayan Churna Given In The Dose Of 1 Gm BD With
The Koshnajala For 30 Days In The Management Of Shwitra By VASI Score. |
1To Study Effect Of NavayasaRasayan Churna Given In The Dose Of 1 gm BD With The Koshnajala For 30 Days In The Management Of Shwitra By VASI score at 4th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Study The Assessment Criteria Of Shwitra (Vitiligo)
2.To Observes Adverse Effects.
3.To Assess The Vyadhi According To Etiological Factors In Details.
|
1 Week 2nd Week 3rd Week 4th week |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
29/11/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
shwitra is genral term for whitening of skin .It is a progressive disease, so treatment should start as quickly as possible. As it is social stigma Shwitra (Vitiligo) is characterized by milky white macules on skin. Modern medicine has developed many treatment modalities still a large group of people fail to get the achieved results and is refractory to treatment. In spite of advanced modern technology and medicine the treatment of Vitiligo is not satisfactory. So ayurved texts there are no.of formulations described for Shwitra so we decided to study on
Navayasa Rasayan Churna and Somaraji churnaboth drug are kusthghna property acts on bhrajak pitta. |