| CTRI Number |
CTRI/2025/02/080192 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| 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 clinical study to evaluate the efficacy of Dadrukandvadi lepa and Durvadi lepa in Dadru (Tinea) |
|
Scientific Title of Study
|
A randomized comparative clinical study to determine the efficacy of Dadrukandvadi lepa and Durvadi 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 |
Dr Shubham |
| Designation |
Pg Scholar |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College, Koppa |
| Address |
Department of Kayachikitsa,1st floor, ALN Rao Memorial Ayurvedic Medical College and PG center, Koppa-577126, Chikmagalur Dist., Karnataka, India.
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7404600200 |
| Fax |
|
| Email |
saini040397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Bhat |
| Designation |
HOD and Professor |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College, Koppa |
| Address |
Department of Kayachikitsa,1st floor, ALN Rao Memorial Ayurvedic Medical College and PG center, Koppa-577126, Chikmagalur Dist., Karnataka, India.
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7619412587 |
| Fax |
|
| Email |
drprashanthbhat@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham |
| Designation |
Pg Scholar |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College, Koppa |
| Address |
Department of Kayachikitsa,1st floor, ALN Rao Memorial Ayurvedic Medical College and PG center, Koppa-577126, Chikmagalur Dist., Karnataka, India.
Chikmagalur
KARNATAKA
577126
India |
| Phone |
07404600200 |
| Fax |
|
| Email |
saini040397@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa OPD, First Floor, ALN Rao Memorial Ayurvedic Hospital, kachkal Road, Koppa, koppa Tq, Chikmagaluru Dist, Karnataka, India. 577126 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham |
| Address |
Department of Kayachikitsa,1st floor, ALN Rao Memorial Ayurvedic Medical College and PG center, Koppa-577126, Chikmagalur Dist., Karnataka, India. |
| Type of Sponsor |
Private 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 Shubham |
ALN Rao Memorial Ayurvedic Hospital |
Kayachikitsa OPD, Room no 1, First floor, ALN Rao Memorial Ayurvedic Memorial Ayurvedic Hospital, Koppa-577126, Chikmagalur DIST, Karnataka.577126
Chikmagalur
KARNATAKA |
7404600200
saini040397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aroor Laxminarayana Rao Memorial Ayurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadrukandvadi lepa, Reference: Sharangdharsamhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 25(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: No, Additional Information: lepa mixed with takra | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durvadi lepa, Reference: Bhaishajya Ratanavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 25(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: No, Additional Information: lepa mixed with takra |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group: - 18yrs - 60 years.
2. Subjects of either sex.
3. Subjects diagnosed with Dadru, having symptoms like kandu, pidaka, raga, and utsanna mandala will be included in the study.
4. Subjects with controlled systemic illness such as diabetes mellitus, hypertension etc.
5. Subjects must be capable of giving informed consent, willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
|
|
| ExclusionCriteria |
| Details |
1.Subjects of age group less than 18 and more than 60 years.
2.Subjects with uncontrolled systemic illness such as diabetes mellitus, hypertension etc.
3.Subjects with other skin diseases will be excluded like eczema, scabies, and psoriasis.
4.Subjects not willing to give written consent for study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kandu/ Itching
Daha/ Burning sensation
Utsanna Mandala/ Elevated circular lesion
Pidaka/ Eruption
Raga/ Erythema
Rookshata/ Dryness
Size of lesion
Numbers of lesion
|
20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="3"
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 a single blind randomized comparative clinical study to evaluate the effect of Dadrukandvadi lepa and Durvadi lepa in 20 days. This study comprise of two groups of 30 subjects with kandu (itching), daha ( burning sensation), utsanna mandala (elevated circular lesion), pidaka (eruption), raga (erythema), rukshata (dryness), discharge (serous/blood/pus) associated with Dadru. Study will be conducted in ALN Rao memorial ayurvedic hospitals in koppa , koppa taluk, chikmagaluru district 577126, karnataka, india. Primary out come measure will be kandu (itching), daha ( burning sensation), utsanna mandala (elevated circular lesion), pidaka (eruption), raga (erythema), rukshata (dryness), discharge (serous/blood/pus) in 20 days. |