| CTRI Number |
CTRI/2023/08/056459 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of yava kalka ghruta application in patients with fresh wound for healing |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of yava kalka ghruta as a vrana ropana in the management of sadyovrana |
| 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 Onkar Arvind Bhandare |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7249511234 |
| Fax |
|
| Email |
dr.onkarbhandare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Patil |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Patil |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Onkar Arvind Bhandare |
| Address |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli |
| 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 Onkar Arvind Bhandare |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital Ashta |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA |
7249511234
dr.onkarbhandare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:W19||Unspecified fall. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Madhu Sarpi, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yava Kalka Ghruta, Reference: Chakradatta , Route: Topical, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed case of Sadyovrana Grushta vrana
abrasions
2 Wound size of 5 cm square to 10 cm square |
|
| ExclusionCriteria |
| Details |
1 Diagnosed case of dushta vrana dagdha Vrana
2 Diagnosed case of other than Ghrushta vrana
3 Neurogenic disorder Infected wound chronic non
healing ulcer fracture etc
4 Patients with septicemia bleeding disorder
5 Patients with known case of systemic diseases
such as tuberculosis HIV HbsAg |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of yava kalka ghruta lepa in the management of sadyovrana |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of yava kalka ghruta lepa & madhu sarpi lepa in the management of sadyovrana |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 |
|
Date of First Enrollment (India)
|
28/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As we see the number of patients with abrasion are increased now a days so this study will help the patients for better healing of wounds and reduction of infections grown in wounds. This study is randomized open controlled trial to evaluate the efficacy of yava kalka ghruta lepa in the management of sadyovrana as trial drug and Madhu sarpi as control drug. Trial and control drugs applied in the form of paste on the diagnosed cases of sadyovrana like ointment for 7 days and as per need. After 7 days patient is advice to come on 15 th day for follow up. 42 patients in each group will be studied. Study will be conducted in India. Outcome of study will be asses on better healing and reduction of signs and symptoms of wound. |