| CTRI Number |
CTRI/2022/09/046069 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Jatyadighrita suppository and Diclofenac suppository in managing the pain after surgery in Anorectal disorders |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the efficacy of Jatyadighrita suppository in post operative pain management of Anorectal disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SRINIVASA N V |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
PG scholar DEPT OF SHALYATANTRA, GOVT AYURVEDA MEDICAL COLLEGE,BENGALURU -09
Bangalore
KARNATAKA
560009
India |
| Phone |
9741893296 |
| Fax |
|
| Email |
srinivasnv05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AHALYA S |
| Designation |
PROFESSOR |
| Affiliation |
Government Ayurveda Medical College |
| Address |
PROFESSOR, DEPT OF SHALYATANTRA, GOVT AYURVEDA MEDICAL COLLEGE,BENGALURU -09
Bangalore
KARNATAKA
560009
India |
| Phone |
9845458563 |
| Fax |
|
| Email |
ahalyasharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AHALYA S |
| Designation |
PROFESSOR |
| Affiliation |
Government Ayurveda Medical College |
| Address |
PROFESSOR, DEPT OF SHALYATANTRA, GOVT AYURVEDA MEDICAL COLLEGE,BENGALURU -09
Bangalore
KARNATAKA
560009
India |
| Phone |
9845458563 |
| Fax |
|
| Email |
ahalyasharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government ayurvedic medical College and hospital, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr SRINIVASA N V |
| Address |
Post graduate scholar, Dept of Shalyatanra, Government Ayurveda Medical College, Bengaluru - 560009 |
| 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 SRINIVASA N V |
Government Ayurveda Medical College, Bengaluru |
Government Ayurveda Medical College, SJIIM Hospital, Dhanvantari road, Bengaluru - 560009
Bangalore
KARNATAKA |
9741893296
srinivasnv05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government Ayurveda Medical College Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T889||Complication of surgical and medical care, unspecified. Ayurveda Condition: AGANTUJAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gudavarti, गà¥à¤¦à¤µà¤°à¥à¤¤à¤¿ | (Procedure Reference: Bhashajya Ratnavali, Procedure details: In this group of patients, Jatyadi ghrita suppositories, each suppository having 1g of drug will be inserted into the rectum a day prior to the surgery, soon after the surgery and until 5 days, every 12th hourly.
Along with this patient will be adviced with Antibiotic therapy,sitzbath,and 6gm of sonamuki choorna with 60ml milk at bedtime.)
(1) Medicine Name: Jatyadighrita suppository , Reference: Astanga hridaya uttaratantra, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: bd, Duration: 5 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Diclofenac suppository | In this group of patients, Diclofenac sodium(50mg) suppository will be administered into the rectum a day prior to surgery, soon after the surgery and until 5 days every 12th hourly. Study will be carried out for 5days
Along with this patient will be adviced with Antibiotic therapy,sitzbath and 6gm of sonamuki choorna with 60ml milk at bedtime. |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing fissurectomy, hemorrhoidectomy, fistulotomy.
2) Patients between the age group of 20 to 60 years were included in the study |
|
| ExclusionCriteria |
| Details |
1. Fissure/hemorrhoid/fistula in ano with Inflammatory Bowel Disease and Crohns disease.
2. Patients suffering from systemic diseases like DM, Tuberculosis, Rheumatoid arthritis.
3. Positive cases for Human Immunodeficiency Virus (HIV), Venereal Disease Research Laboratory (VDRL) and hepatitis-B
4. The post operative cases with complications like severe bleeding, Wound sepsis. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain
2.Baurning sensation |
0th before the day of surgery
Everyday after surgery for 5 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sphincter tone
2.Tenderness |
After surgery daily for 5 days. |
|
|
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" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2022 |
| 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 |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ano rectal disorders are one of the common reasons for visits to both primary care physicians and gastroenterologists, these include fissure-in-ano, hemorrhoids and fistula-in-ano, which in advanced condition requires surgery. In contemporary science diclofenac sodium suppositories which belong to NSAID group are used to relive the pain, but they have adverse effects like headache, drowsiness, rectal irritation, rectal bleeding and abdominal pain. In Ayurveda, Matrabasti and Sneha vartis are used to relieve post operative pain. Matrabasti usually requires assistance and the level of comfort is comparatively less because of possibility of oozing out of administered taila. Contemplating on this, here an attempt will be made for post operative pain management through Jatyadi Ghrita suppository. Jatyadi ghrita is choosen for the present study, which will be modified into simple, cost effective, patients friendly in Suppository form. The results obtained from the clinical study will be compared with the results obtained from the the standard group which will be treated with Diclofenac suppositories. |