| CTRI Number |
CTRI/2025/03/081625 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE EFFICACY OF DRUG NAMED SPILANTHES ACMELLA MURR. IN THE FORM OF SUPPOSITORY IN THE MANAGEMENT OF POST-OPERATIVE PAIN IN ANO RECTAL SURGERIES LIKE PARTIAL SPHINCTEROTOMY |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SPILANTHES ACMELLA MURR. SUPPOSITORY IN THE MANAGEMENT OF POST-OPERATIVE PAIN IN ANO-RECTAL SURGERIES WITH SPECIAL REFERENCE TO PARTIAL SPHINCTEROTOMY. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr YASHASSU T KULOOR |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,
21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BENGALURU
Bangalore
KARNATAKA
560082
India |
| Phone |
9113611553 |
| Fax |
|
| Email |
yashkuloor24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PADMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,
21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BENGALURU
Bangalore
KARNATAKA
560082
India |
| Phone |
9900410580 |
| Fax |
|
| Email |
drpadmabhats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr YASHASSU T KULOOR |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,
21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BENGALURU
Bangalore
KARNATAKA
560082
India |
| Phone |
9113611553 |
| Fax |
|
| Email |
yashkuloor24@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,
21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BENGALURU |
|
|
Primary Sponsor
|
| Name |
Dr YASHASSU T KULOOR |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,
21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BENGALURU |
| 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 YASHASSU T KULOOR |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura Post, Bengaluru- 560082 Bangalore KARNATAKA 560082 India
Bangalore
KARNATAKA |
9113611553
yashkuloor24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Spilanthes acmella Murr., Reference: NA, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(mg), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: Suppository is inserted 8th hourly | | 2 | Comparator Arm (Non Ayurveda) | | - | DICLOFENAC SUPPOSITORY 50MG | DICLOFENAC SUPPOSITORY 50MG IS INSERTED 8TH HOURLY POST SURGERY (PARTIAL SPICTEROTOMY) FOR 3 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with post-operative pain who underwent partial sphincterotomy under local anesthesia irrespective of gender, religion, occupation and socio-economic status will be randomly selected for study.
2)Subjects between age group of 21-60 years.
3)Subjects willing to give consent. |
|
| ExclusionCriteria |
| Details |
1)Subjects with a known allergic reaction to Diclofenac sodium.
2)Subjects suffering from infectious diseases like HIV, Hepatitis and Tuberculosis.
3)Immunocompromised subjects. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in post-operative pain |
3 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve the quality of life.[SF-36]
- Generation of in-depth analyzed data on different aspect of the disease.
- Generation of the data on possible unexpected adverse reaction. |
3 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="2"
Months="0"
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
|
1)THIS STUDY HAS BEEN TAKEN UP TO TO EVALUATE THE EFFICACY OF SPILANTHES ACMELLA MURR. SUPPOSITORY IN THE MANAGEMENT OF POST-OPERATIVE PAIN IN ANO-RECTAL SURGERIES WITH SPECIAL REFERENCE TO PARTIAL SPHINCTEROTOMY 2)THE COMPARISION OF THE STUDY IS WITH DICLOFENAC SUPPOSITORY
3)HYPOTHESIS:-
NULL HYPOTHESIS :- H0 :- There is no difference in the efficacy of Spilanthes acmella Murr. suppository and Diclofenac sodium suppository in the management of post-operative pain in ano- rectal surgeries with special reference to Partial Sphincterotomy. ALTERNATE HYPOTHESIS :- H1 :- The efficacy of Spilanthes acmella Murr. suppository is better than Diclofenac sodium suppository in the management of post-operative pain in ano- rectal surgeries with special reference to Partial Sphincterotomy. H2 :- The efficacy of Diclofenac sodium suppository is better than Spilanthes acmella Murr. suppository in the management of post-operative pain in ano- rectal surgeries with special reference to Partial sphincterotomy. |