| CTRI Number |
CTRI/2025/08/092894 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study on ayurvedic treatments such as Durvadi Ghrita(pichu) and Jatyadi Ghrita (Pichu)with Manual anal dilatation in the patients of Fissure in Ano |
|
Scientific Title of Study
|
A Clinical Study to evaluate the effect of Durvadi Ghrita and Jatyadi Ghrita with manual anal dilatation in Parikartika W.S.R to 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 |
Dr Anita Patel |
| Designation |
Professor |
| Affiliation |
Shree Swaminarayan University, Kalol |
| Address |
Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At and po Saji Ta Kalol Dist Gandhinagar Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
9176945090 |
| Fax |
|
| Email |
dranitasudha@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Patel |
| Designation |
Professor |
| Affiliation |
Shree Swaminarayan University, Kalol |
| Address |
Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At and po Saji Ta Kalol Dist Gandhinagar Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
9176945090 |
| Fax |
|
| Email |
dranitasudha@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarika Gupta |
| Designation |
Medical Officer |
| Affiliation |
Primary Health Centre Hariachak |
| Address |
PHC Hariachak, Tehsil Hiranagar Dist Kathua
Jammu and Kashmir
Kathua
JAMMU & KASHMIR
184148
India |
| Phone |
9596951194 |
| Fax |
|
| Email |
drsarikagupta94@gmail.com |
|
|
Source of Monetary or Material Support
|
| PHC Hariachak , Tehsil Hiranagar, dist. Kathua (J&K) Pin 184148 |
|
|
Primary Sponsor
|
| Name |
Dr Sarika Gupta |
| Address |
Medical Officer Primary Health Centre Hariachak. Dist. Kathua jammu and kashmir |
| 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 Sarika Gupta |
PHC Hariachak |
OPD, IPD,Primary Health Centre Hariachak,Tehsil Hiranagar, Dist. Kathua Jammu and Kashmir
Kathua
JAMMU & KASHMIR |
09596951194
drsarikagupta94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICAL COMMITTEE, SWAMINARAYAN UNIVERSITY, KALOL |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durvadi ghrit, Reference: Bhaishajya Ratnavali vran shoth chikitsa adhyaya by Ambika Dutt Shastri, 14th edition 2001, 47/80., Route: Rectal, Dosage Form: Ghrita, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Per rectal application of Durvadi ghrit pichu daily along with manual anal dilatation for 21 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatyadi ghrit, Reference: Ashtang Hridya Uttarsthan 25/67, Route: Rectal, Dosage Form: Ghrita, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Per rectal application of Jatyadi ghrit pichu daily along with manual anal dilatation for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between the age of 18 to 60 years will be taken irrespective of sex, religion, occupation, and economic status.
2. Patients fulfilling the above-mentioned diagnostic criteria.
3. Patients having classical features of acute fissure-in-ano like Kartanvat vedana, Daha, Vibandha, Rakta-srva and kandu will be included.
|
|
| ExclusionCriteria |
| Details |
1. Fissure secondary to ulcerative colitis, tuberculosis, syphilis, Crohn’s disease and other systemic diseases pertaining to colorectum will be excluded from the study.
2. Patient with Ca rectum, Ca anus, Fistula in ano and hemorrhoids will be excluded.
3. Patient for not willing to undergo the procedure.
4. Portal hypertension.
5. Anal deformity.
6. Hypertension within the range of 140/90.
7. Diabetes Mellitus- specially HbA1c cases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Does Durvadi Ghrita show more effect in comparison to Jatyadi Ghrita in the management of Parikartika (Fissure in ano) |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Role of Durvadi Ghrita with manual anal dilatation in the treatment of Parikartika.
Role of Jatyadi Ghrita with manual anal dilatation in the treatment of Parikartika. |
42 Days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/08/2025 |
| 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
|
Anal fissure is one of the major causes for pain of anal region. An anal fissure is a longitudinal tear in the skin of the anal canal distal to the dentate line. The disease fissure in ano can be compared with Parikartika according to Ayurveda. The disease Parikartika has been described in Charaka Samhita sidhisthana chapter 7 in Niruhabasti Vyapd. In the present study, an effort is made to derive a standard, cost effective and easily accessible treatment for fissure-in-ano from classical resources. The efficacy of Durvadi Ghrita and Jatyadi Ghrita in the management of Parikartika is evaluated in this study. 120 patients are taken in this study and randomly divided into 2 groups. (Each group having 60 patients) Group 1 - 60 Patients receive local application of Durvadi Ghrita and Group 2 - 60 Patients receive local application of Jatyadi Ghrita along with manual anal dilatation.
Durvadi Ghrita and Jatyadi Ghrita are the non-invasive, easy and cost-effective without any adverse effects management for fissure-in-ano and also better alternatives in place of modern techniques, especially in acute fissure-in-ano.
• PROCEDURE: - Per rectal application of Durvadi Ghrita and Jatyadi Ghrita pichu (3ml each) daily along with manual anal dilatation. • DURATION: - 21 days or till symptoms relief. • SITZ BATH: - Every 6hrly and after defecation with lukewarm water. • FOLLOW UP: - after completion of study duration follow up for 7th, 14th, 21st days.
• STUDY DURATION: - 42 days. |