| CTRI Number |
CTRI/2023/04/051830 [Registered on: 20/04/2023] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| 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
|
Effect of Darvinimba Kashay orally and Durva nisha Lepa locally with Laghumangishthadi kashay orally and Durva nisha Lepa locally in skin disease Dadru |
|
Scientific Title of Study
|
Randomized Control Clinical study to evaluate combined systemic and local effect of
Darvikhadirnimba Kashaya Durva Nisha lepa with Laghu Manjisthadi Kashaya Durva Nisha
lepa in Dadru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhanashri Dnyandeo Thube |
| Designation |
MD Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Kayachikitsa OPD 2 ground fllor and ward 2 at first floor
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Kayachikitsa OPD 2 ground fllor and ward 2 at first floor
Pune
MAHARASHTRA
411028
India |
| Phone |
8999877072 |
| Fax |
|
| Email |
dhanuthube97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Sujay Patil |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Kayachikitsa OPD 2 ground fllor and ward 2 at first floor
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Kayachikitsa OPD 2 ground fllor and ward 2 at first floor
Pune
MAHARASHTRA
411028
India |
| Phone |
9665429186 |
| Fax |
|
| Email |
drvrmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanashri Dnyandeo Thube |
| Designation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Kayachikitsa OPD 2 ground fllor and ward 2 at first floor
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Kayachikitsa OPD 2 ground fllor and ward 2 at first floor
Pune
MAHARASHTRA
411028
India |
| Phone |
8999877072 |
| Fax |
|
| Email |
dhanuthube97@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 Kayachikitsa OPD 1 & 2 ground floor and Ward 2 IPD first floor |
|
|
Primary Sponsor
|
| Name |
Dr Dhanashree Dnyandeo Thube |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 Kayachikitsa OPD 1 & 2 ground floor and Ward 2 IPD first floor |
| 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 Dhanashri Dnyandeo Thube |
Saneguruji Arogya kendra |
Saneguruji Arogya Kendra Malwadi Hadapsar Pune 411028 Kayachikitsa OPD 1 & 2 ground floor and Ward 2 IPD first floor
Pune
MAHARASHTRA |
8999877072
dhanuthube97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvikhadirnimba Kashay , Reference: Ashtang Hruday, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -(2) Medicine Name: Durva Nisha Lepa, Reference: Sharangdhar, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghumanjishthadi Kwatha, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -(2) Medicine Name: Durva Nisha Lepa, Reference: Sharangdhar, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sex in beween 10 to 60 years of age with classical signs and
symptoms of Dadru Kushth were included in trial
The patients of both genderirrespective of caste socio-economic statusreligion
commmmunity etc |
|
| ExclusionCriteria |
| Details |
Patient on steroid treatment
Tinea associated with other skin diseases
Tinea Unguium and Tinea Incognito
HIV infected patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Darvikhadirnimba kashay and Durva nisha Lepa on skin disease Dadru on 1 Colour Changes(Raag)
2 Kandu(Itching)
3 Pidika(Lesion) Size No. Of Lesion |
10th 20th 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of Darvikhadirnimba kashay and Durva nisha Lepa on skin disease Dadru on 1 Colour Changes(Raag)
2 Kandu(Itching)
3 Pidika(Lesion) Size No. Of Lesion |
Inclusion 10th 20th 30th day |
Effect of Laghumanjishthadi Kashay and Durva nisha lepa on skin disease Dadru on 1 Colour Changes(Raag)
2 Kandu(Itching)
3 Pidika(Lesion) Size No. Of Lesion |
Inclusion 10th 20th 30th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In contemporary medical science, management of Tinea is carried out with usage of topical or systemic antifungal, corticosteroids. Long lasting usage produce the adverse effect also. As allopathic management in Dadru kushth is costly and not affordable to all .Possible palliative treatment is with Ayurveda, which is effective. This trial contains two groups in Trial group which contains Darvikhadirnimba Kashay 20 lm orally twice a day after meal with Durva nisha Lepa locally twice a day both for 30 days and Control group which contains Laghumanjishthadi Kashay 20 ml twice a day after meal with Durva nisha Lepa locally both for 30 days. Evaluation of drug will be done on 1 Colour Changes(Raag), 2 Kandu(Itching) , 3 Pidika(Lesion) Size No. Of Lesion. |