| CTRI Number |
CTRI/2025/03/082107 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of pathadi churna and navakashaya guggulu along with trina tail malahara in the patients with dermatophytosis |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of pathadi churna and navakashaya guggulu with trina taila malahara in the management of dadru kushtha w.s.r. to dermatophytosis. |
| 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 Chetan Prakash Meena |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College ambamata radaji circle Udaipur 313001 |
| Address |
Madan mohan malviya government ayurved college ambamata radaji circle Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9462548515 |
| Fax |
|
| Email |
cppratihar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Jaiman |
| Designation |
Lecturer |
| Affiliation |
Madan mohan malviya government ayurved college ambamata radaji circle Udaipur 313001 |
| Address |
Madan mohan malviya government ayurved college ambamata radaji circle Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414854839 |
| Fax |
|
| Email |
Djaiman764@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Prakash Meena |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college ambamata radaji circle Udaipur 313001 |
| Address |
Madan mohan malviya government ayurved college ambamata radaji circle Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9462548515 |
| Fax |
|
| Email |
cppratihar@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.M.M.government ayurved college udaipur 313001 rajasthan india |
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya government ayurved college ambamata radaji circle Udaipur |
| Address |
M.M.M.government ayurved college udaipur 313001 rajasthan india |
| Type of Sponsor |
Government medical college |
|
|
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 Chetan prakash meena |
Madan mohan malviya government ayurved college udaipur |
OPD no.1 department of kaya chikitsa M.M.M.government ayurved college ambamata rada ji circle udaipur (raj.)313001
Udaipur
RAJASTHAN |
9462548515
cppratihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MMM.GOVT. AYURVED COLLEGE UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trina Taila Malahara, Reference: Chakradatta Kushtha Chikitsa 50/123, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathadi Churna, Reference: Asthanga Hridaya Chikitsa Sthana 19/40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navakashaya Guggulu, Reference: Chakradatta Visarpa Chikitsa 53/19, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in clinical trial.
2. The patients of either sex having age between 18 to 60 years.
3. The patients having clinical signs and symptoms of Dadru Kushtha w.s.r. to Dermatophytosis.
4. Patients with chronicity of illness less than 5 years. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years and above 60 years.
2. Patients with chronicity of illness more than 5 years.
3. Patients with long term history of steroid and cytotoxic treatment.
4. Patients having concomitant illness like uncontrolled Hypertension, Diabetes mellitus, HIV, Malignancy etc.
5. Patients having other associated skin disease like eczema, secondary bacterial infection etc.
6. Pregnant or lactating women.
7. Patient participated in any clinical trial with in last six months. |
|
|
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 |
| Relief in number of patient |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment |
15th day, 30 day |
|
|
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)
|
18/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is about evaluating the efficacy of pathadi churna and navakashaya guggulu with trina taila malahara in the management of dadru kushtha w.s.r. to dermatophytosis. Selection of 60 patients having Dadru Kushtha/Dermatophytosis symptoms as per inclusion and exclusion criteria
patients are divided into 2 group (30 in each group) Assessment Dadru Kushtha/dermatophytosis symptoms with subjective and objective parameters Evaluate the effect of Pathadi Churna, Navakashaya Guggulu with Trina Taila Malahara in patients Observe the collected data and statistically analyze Result will be interpreted.
|