| CTRI Number |
CTRI/2021/11/037921 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Darviyadi ointmet] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of Darviyadi Ointment and Betadine Ointment (10%) in treatment of Infected Wound. |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the efficacy of Darviyadi Ointment with Betadine Ointment (10%) in the management of Dushta vrana (Infected Wound) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JANESH GUPTA |
| Designation |
M S SCHOLAR SHALYATANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9814034567 |
| Fax |
|
| Email |
guptas34567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARCHANA SHINDE KUKADE |
| Designation |
ASSO-PROFESSOR SHALYATANTRA DEPARTMENT |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9423065167 |
| Fax |
|
| Email |
archanakukde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ARCHANA SHINDE KUKADE |
| Designation |
ASSO-PROFESSOR SHALYATANTRA DEPARTMENT |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9423065167 |
| Fax |
|
| Email |
archanakukde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR JANESH GUPTA |
| Address |
OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18 |
| 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 JANESH GUPTA |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18
Pune
MAHARASHTRA |
9814034567
guptas34567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND RECOGNITION COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Betadine ointment 10%, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Betadine ointment 10% will be applied on 0th, 3rd, 7th, 9th, 11th, 13th day | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having sign and symptoms of Dushta Vrana like: srava, gandha, daha, vedana, kandu.
2)Those who are willing and fulfill 2 out of 5 from the above criteria will be included.
3)Dushta vrana size maximum upto 5cm length and 5cm breadth.
4) Patients of controlled Hypertension on their regular medicines will be included. |
|
| ExclusionCriteria |
| Details |
1) Patients having Diabetes Mellitus, Septicemia and Anaemia (Hb<10gm%).
2) The patients suffering from systemic diseaes such as Hepatitis-B, Malignancy, Varicose ulcer, Deep vein thrombosis, Arterial ulcer, Neurogenic ulcer, Leprosy, Pregnancy, Leukemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Shodhana effect of Darviyadi Ointment in Vrana Srava in Dushta Vrana. |
Application of the drug will be on 0th, 3rd, 7th, 9th, 11th and 13th day.
Assessment will be done on 0th, 7th and 15th day.
Total treatment period will be of 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To do analytical and objective study on Darviyadi Ointment.
2)To study the Ropan properties of Darviyadi Ointment.
3)To study the adverse effects of Darviyadi Ointment. |
Each group will be having 18 patients and will treated with Darviyadi ointment and Betadine ointment (10%) respectively and will be applied on 0th, 3rd, 7th, 9th, 11th and 13th day.
Assessment will be done on 0th, 7th and 15th day.
Total time of study will be 15 days. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a randomized controlled clinical comparative study of Darviyadi ointment with Betadine ointment (10%) in the management of Darviyadi Vrana (Infected Wound). This trial will be carried out on 36 patients and will be divided in two groups (Group A and Group B) of 18 each. Either Ointment’s will be applied on 0th, 3rd, 7th, 9th, 11th and 13th day on patients in either group. The total duration of the study will be 15days. The patients selected for the study will be of age from 18 years upto 60 years. |