| CTRI Number |
CTRI/2022/10/046230 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| 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
|
Clinical trial of Dadimadi Adra Lepa on skin in Dark spots. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Dadimadi Ardra Twak Lepa for external use in Vyanga Vyadhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Dilip Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College PG Training Centre Kodoli |
| Address |
Department of Samhita Siddhant 2nd Floor Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7666179565 |
| Fax |
|
| Email |
dr.mukeshchaudhari18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin S Waghmare |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurved College PG Training Centre Kodoli |
| Address |
Department of Samhita Siddhant 2nd Floor Yashwant Ayurved College PG Training Centre Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822472010 |
| Fax |
|
| Email |
swwaghmaresachin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Dilip Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College PG Training Centre Kodoli |
| Address |
Department of Samhita Siddhant 2nd Floor Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7666179565 |
| Fax |
|
| Email |
dr.mukeshchaudhari18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurved College Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Mukesh Dilip Chaudhari |
| Address |
Department of Samhita Siddhant 3rd floor Yashwant Ayurved College PG Training Centre Kodoli |
| 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 Mukesh Dilip Chaudhari |
Yashwant Ayurved College PG Training Centre Kodoli |
OPD No 17 Kayachikitsa OPD kodoli
Kolhapur
MAHARASHTRA |
7666179565
dr.mukeshchaudhari18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjun Twakadi Lepa, Reference: Yoga Ratnakara, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadimadi Adra Twak Lepa, Reference: Rasaratnakara, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group 20 to 60.
2)Irrespective of Gender.
3)Patient with classical signs and symptoms of Vyanga vyadhi
4)Chronicity less than 3 years
|
|
| ExclusionCriteria |
| Details |
1)with present history of skin disease eg Psoriasis, Acne Vulgaris, Dermatitis, Vitiligo etc. related to face.
2)Person suffering from any infective or contagious skin disease or under medication with antibiotic, antifungal and steroids.
3)Patient of uncontrolled Hormonal disease.
4)Any skin allergy. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Sign and symptoms of Vyang Vyadhi. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Dark patches on face. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/10/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized open controlled clinical study to evaluate the efficacy of Dadimadi Adra Twak Lepa for external use in Vyang Vyadhi . Study will be carried in opd of kayachiktsha department of yashwant ayurvedic college and hospital , kodoli. The observation would be drawn on the basis of treatment given. |