| CTRI Number |
CTRI/2024/12/078316 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| 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
|
TO STUDY EFFICACY OF KADAMBA GHANA VATI IN PAIN MANAGEMENT
|
|
Scientific Title of Study
|
OPEN RANDOMIZED CONTROL CLINICAL TRIAL OF KADAMBA GHANA VATI IN POST OPERATIVE PAIN MANAGEMENT |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Dinesh Gunjal |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli |
| Address |
Department of Shalyatantra OPD No.13 Hon.Shri.Annasaheb Dange Ayurvede Medical College and Post Graduate Research Centre,Tal.Walwa, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
8793644487 |
| Fax |
|
| Email |
prajaktagunjal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManoj Patil |
| Designation |
Professor |
| Affiliation |
Hon Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli |
| Address |
Department of Shalyatantra OPD No.13 Hon.Shri.Annasaheb Dange Ayurvede Medical College and Post Graduate Research Centre,Tal.Walwa, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManoj Patil |
| Designation |
Professor |
| Affiliation |
Hon Annasaheb Dange Ayurved Medical College Ashta TAQ Walwa Dist Sangli |
| Address |
Department of Shalyatantra OPD No.13 Hon.Shri.Annasaheb Dange Ayurvede Medical College and Post Graduate Research Centre,Tal.Walwa, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Hospital Hon.Shri.Annasaheb Dange Ayurvede Medical College and Post Graduate Research Centre,Tal.Walwa, Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Sangli |
| Address |
Department of Shalyatantra OPD No.13 Hon.Shri.Annasaheb Dange Ayurvede Medical College and Post Graduate Research Centre,Tal.Walwa, Ashta 416301 |
| 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 Prajakta Dinesh Gunjal |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli |
Department of Shalyatantra OPD No.13 Hon.Shri.Annasaheb Dange Ayurvede Medical College and Post Graduate Research Centre,Tal.Walwa, Ashta
Sangli
MAHARASHTRA |
8793644487
prajaktagunjal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangli 416301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T148||Other injury of unspecified body region. Ayurveda Condition: other, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kadamba Ghana Vati, Reference: Sushrut Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Ghana Vati, Reference: Sushrut Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting classical signs and symptoms of Post operative pain.
2 Patients of both gender in age group 18-70 years included.
3 All postoperative patients of minor operative procedures.
4 Minor surgeries like corn, lipoma, sebaceous cyst, fibroadenoma.Â
|
|
| ExclusionCriteria |
| Details |
1 Patients reluctant to take treatment.
2 The age group below 18 years and above 70 years.
Known case of Immuno-compromised patient.
3 Systemic disease like AIDS, Tuberculosis, mentally retarded.
4 All major operative procedures |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done with the symptom -pain by using vas scale of pain |
Operative day post operative 1 2 3 4 and 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done with the symptom -pain by using vas scale of pain |
Final outcome will be assessed at post operative day 5 |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/01/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The patient undergoes from minor surgery experiences post operative pain .This pain can be in
form of mild, moderate and sever .The prevalence of post operative pain was 84.17% ,92.5% and
96.66% on the fifth operative hour ,second and third post operative day respectively .Kadamba Ghana Vati explain as a vedanasthapk in charak samhita and ashtang sangrah by achyaryas.The
vedanasthapan karm of kadamba done by its prabhav.Inclusion of Kadamba also in a Nyagrodhadi gana by sushrut acharya in sushrut samhita.
Study time - 5 days Follow up - operative day post operative -1st day 2nd day 3 rd 4th 5th day
Drug dose - 250mg BID AFTER FOOD
Study duration -1year 6 months |