| CTRI Number |
CTRI/2025/07/091275 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| 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
|
A Comparative Pharmaco-Clinical Study of Palash and Chakramarda in the managenant of Dadru kustha |
|
Scientific Title of Study
|
A Comparative Pharmaco-Clinical Study of Palash (Butea monosperma Lam.kuntze) and Chakramarda (Cassia tora Linn) in the managenant of Dadru kustha |
| 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 Ajay kurmi |
| Designation |
MD Scholar Dravyaguna |
| Affiliation |
Pt.khushi lal sharma government Autonomus Ayurveda collage and institute science bhopal |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9713543709 |
| Fax |
|
| Email |
ajaykurmi020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Sharma |
| Designation |
Reader Dravyaguna |
| Affiliation |
pt khushilal sharma ayurveda collage bhopal |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9926379195 |
| Fax |
|
| Email |
Sharmavinod389@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAjay kurmi |
| Designation |
MD Scholar Dravyaguna |
| Affiliation |
Pt.khushi lal sharma government Autonomus Ayurveda collage and institute |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9713543709 |
| Fax |
|
| Email |
ajaykurmi020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003 |
|
|
Primary Sponsor
|
| Name |
Pt.khushi lal sharma government Autonomus Ayurveda collage and institute science bhopal mp |
| Address |
Pt.khushi lal sharma government Autonomus Ayurveda collage and institute science hills behind manit bhopal mp 462003 |
| Type of Sponsor |
Other [state Government Ayurveda collage and institute] |
|
|
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 |
| DrAjay kurmi |
Pt.khushi lal sharma government Autonomus Ayurveda collage and institute bhopal |
Pt.khushi lal sharma government Autonomus Ayurveda collage and institute science hills behind manit bhopal mp 462003
Bhopal
MADHYA PRADESH |
09713543709
ajaykurmi020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: chakramarda, Reference: dhanvantari nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - used on oral and local appliction | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: palash, Reference: bhavpraksh nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -used oral and local application |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 21-50 years without any discrimination of gender,
caste, and religion, Patients fulfilling the diagnostic criteria.
Individuals having clinical sign and symptoms of Dadru roga according to
Ayurvedic classics.
Individuals who will give written consent for the study. |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactating mothers.
Subject having skin disorder other than Dadru.
Immunocompromised patient (HIV, T.B.,) other complicated disorder
uncontrolled diabetes, skin cancer, psoriasis, malignant of skin diseases,
Generalized eczema, hansen’s disease, cellulitis and other autoimmune disease
Patient who used to Immunosuppressive drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the reduction or elimination of symptoms like itching (Kandu), redness (Raga), eruptions (Pidika), and elevated circular skin lesions (Utsanna Mandala). Successful treatment aims to alleviate these symptoms and prevent recurrence. |
7 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complete Blood Count (CBC)
RBS |
45 days |
|
|
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)
|
02/09/2025 |
| 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
|
Aim of the study is to provide a simple, safe and herbal drug for patient of Dadru kustha and Evaluation of efficacy palash beej churna and chakramard beej churna
Participants
fulfilling the inclusion criteria will be selected. Those patients will
be selected, who fulfils the criteria of selection and attended the OPD of
department of kayachikitsa at Pt. Khushilal Sharma Govt. (Auto.)
Ayurveda College and Institute Bhopal. The clinical trial will be taken
out on 40 (20 Participants in each group) and they were randomly selected and
divided into 2 groups:
Group A-
Study group
Group B-
Study group
Including symptoms: kandu ,raga,pidika,daha,Rooksha,Uttana mandala
Assessment
criteria: Subjective parameters will be scored as mentioned in specially
designed scale and will be compared before and after treatment.
Objective
parameter will also be compared at the same interval.
The
assessment criteria for Dadru kustha will be mainly based on:
[a]
Subjective criteria: 1.Kandu (itching)
2.Raga (Erythema)
3.Pidaka
4.Daha
5.Rooksha
6.Unnata mandala (Raised border ring)
[b].
Objective criteria:
Investigation:
Blood: CBC,RBS
|