| CTRI Number |
CTRI/2024/09/074189 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Drug Khadirashtak Kwath and Kusthadi Lepa in Dadru(Dermatophytosis). |
|
Scientific Title of Study
|
A Clinical Study To Evaluate the Effect of Khadirashtak Kwatha and Kusthadi Lepa in Dadru. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chanda Pal |
| Designation |
Pg Scholar |
| Affiliation |
Uttarakhand Ayurveda University, Gurukul Campus |
| Address |
OPD NO 5 Department of Kayachikitsa, Uttarakhand Ayurveda University, Gurukul Campus Hardwar.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7900235455 |
| Fax |
|
| Email |
chandapal1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Dinesh Kumar Goyal |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University, Gurukul Campus |
| Address |
OPD NO 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Hardwar.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411731180 |
| Fax |
|
| Email |
dineshdr157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chanda Pal |
| Designation |
Pg Scholar |
| Affiliation |
Uttarakhand Ayurved University, Gurukul Campus |
| Address |
OPD NO 5 Department of Kayachikitsa, Uttarakhand Ayurveda University, Gurukul Campus Hardwar.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7900235455 |
| Fax |
|
| Email |
chandapal1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Kayachikitsa , Uttarakhand Ayurveda University, Gurukul Campus Haridwar 249404. |
|
|
Primary Sponsor
|
| Name |
DR CHANDA PAL |
| Address |
PG Department of Kayachikitsa, Uttarakhand Ayurveda University, Gurukul Campus Haridwar 249404. |
| 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 CHANDA PAL |
Uttarakhand Ayurveda University, Gurukul Campus, Hardwar. |
OPD NO 5 Department Of Kayachikitsa
Hardwar
UTTARANCHAL |
7900235455
chandapal1997@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee UAU Gurukul Campus, Hardwar. |
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: khadirashtak kwatha, Reference: yog ratnakar page no. 219/2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: kusthadi lepa, Reference: bhavprakash 145/54, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients that exhibit typical signs and symptoms of
Dadru(KANDU, RAGA, PIDIKA, UTSANNA MANDALA).
Chronicity less than 5 years. |
|
| ExclusionCriteria |
| Details |
Age group less than 20years and more than 60 years.
Pregnant and lactating woman.
Chronicity more than 5 years.
Patient suffering from diabetes mellitus.
Any other co-existing skin disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
relief in subjective parameters
1.kandu
2.Raga
3.Pidika |
Assessment will be done at 15th day, 30th day and 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in objective parameters,
1. mandala
2. surface area of lesion (Utsanna mandala) |
Assessment of patient will be done at 15th day,30thnday & 45th 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 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an open label of clinical trial to determine the efficacy of Khadirashtak kwatha and Kusthadi lepa in Dadru for age group between 20-60 years, for 45 days. The study will be conducted at Uttarakhand Ayurveda University Gurukul Campus, Haridwar on 40 patients. The assessment will be done on the basis of subjective and objective parameters. The study will be conducted at OPD/IPD level of P.G. department of kaya chikitsa . The assessment will be done at the interval of 15 days of the clinical trial and the results obtained will be tabulated and statically analyzed using appropriate tests. |