| CTRI Number |
CTRI/2025/05/087225 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Clinical Study on the Efficacy of Khadiradi Kashay and Dadrudavanal Lepa in Treating Dadru Tinea Corporis |
|
Scientific Title of Study
|
Comparative clinical study to evaluate efficacy of khadiradi kashay with dadrudavanal lepa in the management of dadru with special reference to Tinea corporis |
| 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 Prajkta Anil Inamdar |
| Designation |
MD Scholar |
| Affiliation |
Shree Saptshrungi Ayiurved Mahavidyalaya And Hospital,Nashik |
| Address |
OPD No 2,Department of Kayachikitsa Shree Saptshrungi Ayurved Mahavidyalay And Hospital,Kamal nagar, Hirawadi, Panchvati
Nashik
MAHARASHTRA
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
7066692947 |
| Fax |
|
| Email |
prajktainamdar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Sachin Patil |
| Designation |
Professor |
| Affiliation |
Shree Saptshrungi Ayiurved Mahavidyalaya And Hospital,Nashik |
| Address |
OPD No.2 Department of Kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya and Hospital,Kamal Nagar,Hirawadi,Panchavati,Nashik ,Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422119169 |
| Fax |
|
| Email |
drkavitasp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Sachin Patil |
| Designation |
Professor |
| Affiliation |
Shree Saptshrungi Ayiurved Mahavidyalaya And Hospital,Nashik |
| Address |
OPD No.2 Department of Kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya and Hospital,Kamal Nagar,Hirawadi,Panchavati,Nashik ,Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422119169 |
| Fax |
|
| Email |
drkavitasp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptshrungi Ayurved Medical college and Hospital,Kamal Nagar,Hirawadi,Panchavati,Nashik
Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptshrungi Ayurved Mahavidyalay, Kamal nagar, Hirawadi, Panchvati, Nashik |
| Address |
Department of Kayachikitsa, Shree Saptshrungi Ayurved Mahavidyalay,Kamal nagar, Hirawadi, Panchvati, Nashik, Maharashtra 422003 |
| 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 Prajkta Anil Inamdar |
Shree Saptshrungi Ayurved Medical College and Hospital |
Department of Kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya and Hospital,Kamal Nagar,Hirawadi,Panchavati,Nashik,Maharashtra 422003
Nashik
MAHARASHTRA |
7066692947
prajktainamdar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptshrungi Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadiradi kashay, Reference: yoga Chintamani , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita, Procedure details: lepa apply on infected site of skin.)
(1) Medicine Name: Dadrudavanadi lepa, Reference: Siddhabhaishjya manimala, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 15 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadiradi kashay (Internal medicine ) and Dadrudavanadi lepa (External medicine), Reference: Yogchintamani and Siddhabhaishyajya manimala, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -In this group external and internal medicine both will give -Dadrudavanadi lepa (externally )REF:Siddhabhaishjya manimala Route :Topical Frequency :OD Duration:15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with classical sign &symptoms of Dadru I.e.kandu,Pidikotpatti, Raga,Utsanna mandala.
2)Patients of either gender and age group between 18-60 years irrespective of religion, occupation and socio-economic status will be selected.
3)Patients having symptoms of dadru kushta within the time period of 6 months |
|
| ExclusionCriteria |
| Details |
1)Patients of Dadru with any secondary complication.
2)Patients who are suffering from any other type of skin disease like Herpes zoster, eczema.
3)Patients who are suffering from any other known case of systemic Diseases I.e.uncontrolled DM etc.
4) Pregnant and lactating women
5)Patients taking immunosuppressive medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce signs and symptoms of dadru (Tinea corporis) |
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce signs and symptoms of dadru (Tinea Corporis)
To reduce recurrence rate of Dadru (Tinea corporis)
To reduce rec |
15 th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
27/05/2025 |
| 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="0"
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
|
Primary Objectives-1.To evaluate & compare the efficacy of khadiradi kashay & dadrudavanadi lepa in the management of Dadru based on clinical improvement in signs & symptoms including kandu (itching),Raga(Erythema or Redness),Pidika (Eruption),Utsanna mandala (Elevated circular skin Lesion),No of Pidika & size of lesion. Secondary Objectives-1.To compare the duration required for significant symptomatic relief & lesion clearance in treatment groups. 2)To study the recurrence of infection within a specific follow up period after completion of therapy 3)To determine whether a combination therapy (oral +topical)provides superior results compared to either alone drug. Participants - 90 adults diagnosed with dadru meeting inclusion & exclusion criteria from shree Saptshrungi Ayurved Mahavidyalay And Hospital Nashik.
Interventions - Group A-Khadiradi kashay internally for 15 days Group B-Dadrudavanadi lepa externally (LA) 15 days Group C-Khadiradi kashay internally and Dadrudavanadi lepa externally (LA)
Treatment duration-15 days Follow up - 0 ,7 th & 15 th day
Data Analysis- Data will be analysed using appropriate statistical Methods to compare the effectiveness of the intervention on the primary and secondary outcomes.
Ethical Consideration-The study will be conducted in accordance with Ethical Guidelines & with informed consent from participants. |