| CTRI Number |
CTRI/2025/03/081949 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Saptang Guggul in Post Operative Pain Management |
|
Scientific Title of Study
|
An open randomized controlled clinical trial of Saptang Guggul 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 |
pranil sunil gholave |
| Designation |
PG Scholar |
| Affiliation |
S.D.S.S Annasaheb Dange Ayurved Medical College, Sangli |
| Address |
Opd no 13,shalyatantra
OPD,ground floor,Dhanvantari ayurveda hospital, Ashta, Tal Walwa
Dist Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
07276066473 |
| Fax |
|
| Email |
pranilgholave123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Patil |
| Designation |
Professor |
| Affiliation |
S.D.S.S Annasaheb Dange Ayurved Medical College, Sangli |
| Address |
Opd no 13,shalyatantra
OPD,ground floor,Dhanvantari ayurveda hospital, Ashta, Tal Walwa
Dist Sangli
MAHARASHTRA
416301
India
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 |
S.D.S.S Annasaheb Dange Ayurved Medical College, Sangli |
| Address |
Opd no 13,shalyatantra
OPD,ground floor,Dhanvantari ayurveda hospital, Ashta, Tal Walwa
Dist Sangli
MAHARASHTRA
416301
India
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 Graduate And Research
Center Ashta Tal Walwa Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Pranil Gholave |
| Address |
Opd no 13,shalyatantra
OPD,ground floor,Dhanvantari ayurveda hospital, Ashta, Tal Walwa
Dist Sangli
MAHARASHTRA
416301
India |
| 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 Pranil Gholave |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Post Graduate & Research Center, Ashta. |
Opd no 13,shalyatantra
opd, ground floor,
dhanvantari ayurved
hospital, Ashta Sangli
416301
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
07276066473
pranilgholave123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: saptang guggul, Reference: Ambikadattashastri, Bhaishajyaratnavali, Varanasi UP, Chaukhambha prakashan, reprint 2018, page no. 865, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Days, anupAna/sahapAna: Yes(details: koshnajal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Diclofenac sodium | Tripathi KD, Essentials of medical pharmacology, 8th edition,
New Delhi, Jaypee Brothers Medical Publishers 2019, reprint
2023, page no. 220
Route: Oral, Dosage form: Tablet, Dose: 50mg, Frequency: BD, Duration: 4 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with classical signs and symptoms of Post operative pain.
2. Patients of both gender in age group 18-70 years included.
3. Patient ready and willing for treatment.
4. Patients including ASA Scale 1 |
|
| ExclusionCriteria |
| Details |
1. Patients reluctant to take treatment.
2. Known case of Immuno-compromised patient. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| saptang guggul is effective in post operative pain management. |
4 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| diclofenac sodium is effective in post operative pain management. |
4 day |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/07/2025 |
| 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="0"
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
|
Pain is defined as ‘An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.’ Patients will experience pain after surgery i.e. Post operative Pain. This pain can be of mild , moderate or severe type. As per principle of Ayurveda vitiation of vata is the prime factor to produce the pain perception. The formulation from bhaishajya ratnavali is indicated as analgesic.
According to Bhaishajya ratnavali, Saptang guggul is indicated in Nadivrana chikitsa adhyay which also has action in shool management. Hence, out of my own interet Saptang guggul is selected for this study.
A comparative clinical trial was designed in the following manner. The patient was selected by simple randomized sampling method. 41 patients were selected in Group ‘A’ and 41 patients were in Group ‘B’. Group‘A’ patients were treated with‘ Saptang guggul’ 1 gm bd and Group‘ B’ patients were treated with tab ‘Diclofenac sodium 50 mg bd For 4 days .’ Follow up Operative day , Post operative1st ,2nd ,3rd day
observations will be done and results will be noted. |