| CTRI Number |
CTRI/2025/12/098816 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| 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
|
A STUDY TO COMPARE CHANGERI GHRITA SUPPOSITORY WITH DICLOFENAC SODIUM SUPPOSITORY FOR REDUCING PAIN AFTER HAEMORRHOIDS SURGERY. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHANGERI GHRITA SUPPOSITORY WITH DICLOFENAC SODIUM SUPPOSITORY IN THE MANAGEMENT OF POST OPERATIVE HAEMORRHOIDECTOMY PAIN. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAHUL GASTI |
| Designation |
Post Graduate Resident |
| Affiliation |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPTIAL, INCHAL |
| Address |
Department of Shalya Tantra,Shalya Tantra OPD,Room No-34 ,Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital ,Inchal ,Karnataka -591102
Belgaum
KARNATAKA
591102
India |
| Phone |
9611876228 |
| Fax |
|
| Email |
rahulgasti007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KUBENDRA H PACHCHINAVAR |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF SHALYA TANTRA |
| Affiliation |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPTIAL, INCHAL |
| Address |
Department of Shalya Tantra,Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital ,Inchal ,Karnataka -591102
Belgaum
KARNATAKA
591102
India |
| Phone |
9880499597 |
| Fax |
|
| Email |
kubendra.pacchinnavar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KUBENDRA H PACHCHINAVAR |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF SHALYA TANTRA |
| Affiliation |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPTIAL, INCHAL |
| Address |
Department of Shalya Tantra,Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital ,Inchal ,Karnataka -591102
Belgaum
KARNATAKA
591102
India |
| Phone |
9880499597 |
| Fax |
|
| Email |
kubendra.pacchinnavar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPTITAL, INCHAL |
|
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Primary Sponsor
|
| Name |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
| Address |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital ,Inchal ,Karnataka -591102 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAHUL GASTI |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPTIAL, INCHAL |
Department of Shalya tantra,Shalya tantra OPD ,room no 34.
Belgaum
KARNATAKA |
9611876228
rahulgasti007@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Changeri ghrita suppository |
Type - Intervention.
Name - Changeri ghrita suppositry.
Dosage form- Rectal suppository.
Dose -2 Suppositories weighting about 2 g .
Route - Rectal.
Duration - 5 days post operavtively.
Frequency- every 12 hourly.
Mode of Preparation-Changeri ghirta will be procured from a GMP certified ayurvedic pharmacy .The formulation is prepared as per classical ayurvedic reference mentioned in Bhaishajaya Ratnavali -Grahaniroga adhikar (6-190-192).For Suppository formation , the Changeri ghirta will be incorporated into a suppository base(coco butter and bee wax) in appropriate proportion.The Mixture will be melted , homogenized,poured into suppository moulds (2 g each), cooled and stored in airtight, light resistent containers under refrigeration untill use.
|
| Comparator Agent |
Diclofenac sodium suppository |
Dosage-75 mg .
Dosage form- Rectal suppository.
Route- Rectal.
Duration-5 days post operatively.
Frequency -every 12 houly.
Diclofenac sodium suppository (75mg)will be procured from a licenced GMP certified pharmaceutical manufacturer .Each diclofenac suppository contain standard fatty base (coco butter). The suppositories are stored according to manufacturers instructions untill use. |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Haemorrhoidectomy .
Patients between the age group of 20-60 years.
Irrespective of gender and occupations.
Controlled Diabetic and Hypertensive patients will be selected for the study. |
|
| ExclusionCriteria |
| Details |
Patient suffering from systemic diseases like Uncontrolled Diabeties and Hypertention, Tuberculosis, Rheumatoid arthritis.
patients with haemorrhoids with IBS and Crohns disease. Postive cases of HIV, VDRL,Hepatitis B, Leprosy.Post operative cases with complications like Severe bleeding , wound sepsis . Cases of Haemorrhoids with fissure, fistula in ano, ischio rectal abscess , perianal abscess and CA Rectum. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in post-operative pain score measured by Visual Analogur scale (VAS) |
at baseline (0 hrs), 12 hrs, 24 hrs, 48 hrs,72 hrs,96hrs and 120 hrs |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Burning pain at site of insertion -
Grade 1-present
Grade 2-absent |
at 30 mins , 1 hr ,2 hr after insertion. |
Tendernessat operative site measured clinically as
Grade1- present
Grade2-absent |
at 24 hrs, 48 hrs , 72 hrs ,96 hrs and 120 hrs |
Duration of pain reduction (after suppository insertion)
Grade1- reduction after 30 mins
Grade2-reduction after 60 mins
Grade3-reduction after 90 mins
Grade4-reduction after 120 mins |
at 30mins, 60mins, 90 mins and 120 mins after insertions of suppository. |
Reoccurence of pain
Grade 1- no pain
Grade 2- after 12 hrs
Grade 3- after 8 hrs
grade 4- after 4 hrs |
at 4hrs, 8 hrs,12 hrs after insertion of suppostory. |
Rescue analgesic requirement yes or no
number of dose required
|
within 0-24 hr, 24-48 hr and upto 5 days post operatively. |
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2026 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This randomized, parallel-group, active-controlled interventional study aims to compare the efficacy of Changeri Ghrita suppository and Diclofenac sodium (75 mg) suppository in managing post-operative pain following hemorrhoidectomy. 40 patients will be enrolled, with 20 in each group. Changeri Ghrita suppositories will be prepared according to Bhaishajya Ratnavali and administered rectally every 12 hours for five days, while Diclofenac suppositories will be administered similarly. The primary outcome is reduction in post-operative pain measured by Visual Analog Scale (VAS). Secondary outcomes include tenderness, burning sensation, duration of pain relief, recurrence, and rescue analgesic use. This study seeks to determine whether Changeri Ghrita suppository is a safe and effective alternative to standard Diclofenac suppository for post-hemorrhoidectomy pain management.
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