| CTRI Number |
CTRI/2025/06/088065 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of katphala caplet in post operative pain management in lower abdominal surgeries. |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study to evaluate the efficacy of katphala caplet with Diclofenac suppository in the management of post operative pain in lower abdominal surgeries. |
| 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 Saiprasad Balaji Kottawar |
| Designation |
MS Scholar Shalyatantra (Ayurveda) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidhyalaya Malwadi Hadapsar Pune MAaharashtra 411028 |
| Address |
Ward 2,IPD Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9146826233 |
| Fax |
|
| Email |
saibalajikottawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi A Kale |
| Designation |
MS PhD Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidhyalaya Malwadi Hadapsar Pune MAaharashtra 411028 |
| Address |
Ward 2,IPD of Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi A Kale |
| Designation |
MS Phd Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidhyalaya Malwadi Hadapsar Pune MAaharashtra 411028 |
| Address |
Ward 2,IPD Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra,Sane Guruji Arogya Kendra,MAMs Sumatibhai Shah Ayurvedic Mahavidyalaya Malwadi Hadapsar Pune Maharashtra India 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
| Address |
OPD No.3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saiprasad Balaji Kottawar |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
OPD No.3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
MAHARASHTRA |
9146826233
saibalajikottawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z488||Encounter for other specified postprocedural aftercare. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katphala , Reference: Charak Samhita Sutrasthana , Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Diclofenac suppository | Medicine Name:-Diclofenac Suppository, Route:Rectal,Dose:1gm,Dosage form: Suppository, |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Post operative patient who have been operated for lower abdominal surgeries,inguino-scrotal surgeries,Ano-rectal surgeries, pelvic floor surgeries, genital surgeries |
|
| ExclusionCriteria |
| Details |
Patients who suffer from diarrhoea,acute fissure,active PR Bleeding,CA rectum,Tuberculosis of abdomen, dysentery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of katphala caplet in post operative pain management as an analgesic |
18 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of katphala caplet with diclofenac suppository |
18 month |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/06/2025 |
| 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
|
Persistent post operative pain it’s common after most surgical procedure, about 50% of patient may experience it.Ophoid remains the main stay of post operative pain treatment in spite of strong evidence of their drawbacks. As pain is the one of the major complaint after the operation and currently available modern medication it causing many side effect and require long term medication which suppresses immunity and produce their diseases. So I choose katphala as drug of choice for post operative pain management. It also act as a Shoolaghna. It’s chemical content Myricetin is a common plant derived flavonoids and is well recognised for its nutraceuticals values. The compound exhibit wide range of activities that include strong antioxidant, anticancer ,pharmacological activities including and Inflammatory analgesic hepato protective and Anti diabetic activities. Previous study has inclusion criteria was on inguino-scrotal surgery but this study having extended group of surgeries having extended group of surgeries such as lower abdominal and pelvic surgeries. Sample size and trial drug are different from previously studies. There is no previous work done on katphala caplet as suppository in post operative pain management. The Katphala is comes under Vednasthapak Gana which acts as a shoolaghna. Vednasthapak Gana is describe the in Charak Samhita Sutrasthana. The properties of Katphala acts on post operative pain management. My main objective is to study the Efficacy of katphala caplet in post operative pain management as analgesic and to compare the efficacy of katphala caplet with diclofenac suppository. |