| CTRI Number |
CTRI/2026/01/100595 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Shyamadi Udvartana externally along with Varadi Churna Orally in patients suffering from fungal skin disease (Kushta -Pityriasis versicolor ) |
|
Scientific Title of Study
|
Randomised open controlled clinical trial to Evaluate the efficacy Of Shyamadi Udvartana For External application along with Varadi Churna Orally in Sidhma Kushta with special reference to Pityriasis versicolor |
| 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 Siddhi Ravindra Bhujbal |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT And RC Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College
Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7775979092 |
| Fax |
|
| Email |
sidbhujbal99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Parshuram Wagh |
| Designation |
HOD KAYACHIKITSA Department |
| Affiliation |
Yashwant Ayurvedic College PGT and RC kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College
Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhi Ravindra Bhujbal |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College
Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7775979092 |
| Fax |
|
| Email |
sidbhujbal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post graduate training and Research centre Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Siddhi Ravindra Bhujbal |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College
Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
MAHARASHTRA 416114 India |
| 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 Siddhi Ravindra Bhujbal |
Yashwant Dharmarth Ruganalaya Kodoli |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College
Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA |
7775979092
sidbhujbal99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Eithical committee Yashwant ayurvedic college PGT And RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B360||Pityriasis versicolor. Ayurveda Condition: SIDHMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Itracanazole 200 mg once a day orally and ointment Miconazole as per extent of lesion locally once a day for 30 days | Reference: Essential of medical pharmacology KD tripathi 8 th edition Anti fungal drug chapter 58, page no.843 and 845 | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varadi churna , Reference: Bharat bhaishajya Ratnakar page no 591 and Vagbhat Chikitsa sthan 19/35 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: -(2) Medicine Name: Shyamadi Udvartana , Reference: Bharat bhaishajya Ratnakar Bhag 5,7332 page no.33 , Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having symptoms of Sidhma Kushta that is twak vaivarnya, Rajoghrushtam Vimuncchati of skin
2. Patient will be selected irrespective of gender and occupation. |
|
| ExclusionCriteria |
| Details |
1.Patient with deep skin infection will excluded psoriasis, eczema, candidiasis,lichen simplex, seborrhic dermatitis
2.Patient known sensitive to sulphur preparation
3.Known history of immunocompromised patient
4.Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Varadi churna internally along with Shyamadi Udvartana locally in Sidhma Kushta |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Shyamadi Udvartana in external application and Varadi Churna internally for sign twak vaivarnya, Rajoghrushtam Vimuncchati in 30 days duration
2.To study Sidhma as per ancient ayurveda
3. To study the modern aspect of Pityriasis versicolor |
30 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="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
|
This is Randomised open controlled clinical trial to evaluate the efficacy of Shyamadi Udvartana For External application along with Varadi Churna Orally in Sidhma Kushta Assessment of signs and symptoms will be done at regular intervals. Observation will be drawn from the outcome of patient after 30 days |