| CTRI Number |
CTRI/2025/07/090242 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of sarvang sundari gutika and eladi lepa in the management of tinea infections ( fungal infection ) |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of sarvang sundari gutika and eladi lepa in the management of dadru w.s.r. to tinea infections |
| 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 ABHISHEK DIXIT |
| Designation |
PG SCHOLAR |
| Affiliation |
Pt. khushilal sharma govt. (auto) ayurveda college and institute bhopal |
| Address |
Room No. 228 PG Department Of Agad tantra Evum Vidhi Vaidyaka Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 India Bhopal MADHYA PRADESH 462003 India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8349868951 |
| Fax |
|
| Email |
dixitabhishek511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR URMILA SHUKLA |
| Designation |
PROFESSOR & H.O.D. |
| Affiliation |
Pt. khushilal sharma govt. (auto) ayurveda college and institute bhopal |
| Address |
Room No 228 Department Of Agad Tantra Evum Vidhi Vaidhyaka Pandit Khushilal Sharma Govt Autonomous Ayurveda College And Institute Bhopal
Madhya Pradesh 462003 India
Bhopal 462003
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425672655 |
| Fax |
|
| Email |
urmila.shukla.393950@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHISHEK DIXIT |
| Designation |
PG SCHOLAR |
| Affiliation |
Pt. khushilal sharma govt. (auto) ayurveda college and institute bhopal |
| Address |
Room No. 228 PG Department Of Agad tantra Evum Vidhi Vaidyaka Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 India Bhopal MADHYA PRADESH 462003 India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8349868951 |
| Fax |
|
| Email |
dixitabhishek511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal 462003
|
|
|
Primary Sponsor
|
| Name |
Pandit Khusilal Sharma Govt Auto Ayurveda College And Institute Bhopal |
| Address |
Science Hill Behind MANIT Kolar Nehru Nagar Bypass Road Bhopal mp |
| 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 ABHISHEK DIXIT |
Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal |
Room no.228 Agad tantra evum
vidhi vaidhyak department Science Hills Behind MANIT Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
Dhar
MADHYA PRADESH |
08349868951
dixitabhishek511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pandit Khusilal Sharma Govt(Auto) Ayurveda Institute Bhopal mp |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarvang sundari gutika, Reference: Yograthnakar samhita kushtha chikitsa adhyay , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | SEMOLINA POWDER CAPSULE | capsule filled with semolina powder.
route- oral
dose- 500 mg for 30 days
frequency - bd
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the signs and symptoms of Dadru according to Ayurvedic and modern Literatures.
2.Patients of age group between 20 to 60 years, irrespective of sex, religion, socioeconomic status and occupation.
3.Patient willing to participate in this study
|
|
| ExclusionCriteria |
| Details |
1.Patients with other chronic Systemic Disease like Diabetes mellitus, Ischemic heart disease, Tuberculosis, malignancy etc.
2.Pregnant and Lactating Women.
3.Patients not willing to sign the written consent form
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we would be able to demonstrate the efficacy of Sarvang Sundari Gutika and Eladi Lepa in the management of Dadru |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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
|
Ayurveda has a many perspective in skin discuses. It cures diseases frown its toot. There are many drugs that are used for skin discases, Some of them are Sarvang sundari gutika and Eladi Lepa that have been mentioned by acharya Yog ratnakar in yogratnakar samhita. These are traditionally used for various skin disorder, including dadru ( Tinea infection ), which is a fungal infection of the skin. Its believed to have anti-fungal and anti-inflammatory properties. |