| CTRI Number |
CTRI/2025/12/099794 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of Matra basti of jatyadi taila and durvadi taila in parikartika (Acute fisssure in Ano) |
|
Scientific Title of Study
|
A comparative clinical study of matra basti of durvadi tail and jatyadi tail in the management of parikartika wsr to acute fissure in ano |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhiranjan Singh Tomar |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Rani Dulliya Smriti Ayurveda PG College And Hospital Barkhedi kalan Bhadbhada Road Bhopal MP
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8319191653 |
| Fax |
|
| Email |
abhiranjan.tomar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Sakhare |
| Designation |
Professor of Shalya Tantra Department |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Rani Dulliya Smriti Ayurveda PG College And Hospital Barkhedi kalan Bhadbhada Road Bhopal MP
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8208586302 |
| Fax |
|
| Email |
sakhare2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhiranjan Singh Tomar |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Rani Dulliya Smriti Ayurveda PG College And Hospital Barkhedi kalan Bhadbhada Road Bhopal MP
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8319191653 |
| Fax |
|
| Email |
abhiranjan.tomar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal (M.P.) 462044 India. |
|
|
Primary Sponsor
|
| Name |
Dr Abhiranjan Singh Tomar |
| Address |
PG Deprtment of Shalya Tantra , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal (M.P.) 462044 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 Abhiranjan Singh Tomar |
Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal |
PG Department of Shalya Tantra OPD No 7 Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal Madhya Pradesh 462044 India
Bhopal
MADHYA PRADESH |
8319191653
abhiranjan.tomar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ehics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadi tail, Reference: Bhaishajya ratnavali ,vrana shothadhikar. (bhaishajya ratnavali vrana shothadhikar chapter 47 shlok numer-77 ,page numbert - 827, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi tail, Reference: Sharangdhar Samhita madhyam khand adhyay 9 shlok number-168-169-170-171 page number -242, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from Parikartika (acute fissure –in- ano ) with symptoms of Painful defecation, burning sensation, bleeding per rectum i.e. stools streaked with blood, constipation, spasm of the sphincter.
2.Patient having solitary (Single) and multiple anal fissures.
3.Patient within the age group of 18 to 60 years of age.
4.Patients will be selected irrespective of cast and religion, gender, habitat, occupation and socio- economic status.
|
|
| ExclusionCriteria |
| Details |
1.Patients having parikartika (Fissure-in-Ano) secondary to known case of Ulcerative colitis, Crohn’s disease, Syphilis and Tuberculosis, Malignancy will be excluded.
2.Patients having chronic fissure in ano (Sentinel tag).
3.HIV and hepatitis B.
4.Uncontrolled diabetes mellitus (Sugar level more than 200 mg/dl).
5.ANC patients.
|
|
|
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 anal pain (measured by pain scale)
Decreased burning sensation in the anal region
Reduction in bleeding per rectum
Improvement in sphincter spasm/anal tightness
Early signs of fissure healing seen on local examination |
5 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Near complete relief from pain and burning sensation
Complete or near-complete stoppage of bleeding per rectum
Normalization of bowel movements with reduced constipation and straining
Improved sphincter relaxation and reduction in spasm |
10 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/01/2026 |
| 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="0"
Months="8"
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
|
This selected clinical trial is a comparative study evaluating the therapeutic efficacy of Matra Basti using Durvadi Taila and Jatyadi Taila in the management of Parikartika (with special reference to acute fissure-in-ano). The study aims to assess and compare the effects of both medicated oils on key symptoms such as anal pain, burning sensation, bleeding per rectum, and sphincter spasm. Matra Basti, a type of oil enema, was administered in both groups following Lord’s anal dilation procedure.
The outcomes were measured based on symptomatic relief, healing of fissure, and improvement in quality of life. The study concluded that both Durvadi Taila and Jatyadi Taila Matra Basti are effective in managing acute fissure-in-ano, with variation in the degree and speed of symptom relief, thereby supporting their clinical utility as safe and effective Ayurvedic interventions for Parikartika. |