| CTRI Number |
CTRI/2025/08/093051 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Oil Applications for Anal Fissures: A Clinical Comparison |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF HINSRADYA TAILA
AND NIRGUNDI TAILA AS PICHU IN THE MANAGEMENT OF
PARIKARTIKA(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 |
HARSHADA KANTIGIR BAWA |
| Designation |
PG RESIDENT |
| Affiliation |
ASHWIN RURAL AYURVED COLLEGE AND HOSPITAL,MANCHI HILL, ASHWI BK. |
| Address |
OPD No-5, Shalyatantra Department,Ashwin Rural Ayurveda College and Hospital ,Manchi Hill , Ashwi Bk. Tal- Sangamner, Dist- Ahmadnagar pin code - 413714
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8010889565 |
| Fax |
|
| Email |
harshadabawa39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD KHANDIZOD SHIVAPAL GOPALRAO |
| Designation |
PROFESSOR |
| Affiliation |
ASHWIN RURAL AYURVED COLLEGE AND HOSPITAL,MANCHI HILL, ASHWI BK. |
| Address |
OPD no-5, Shalyatantra Department, Ashwin Rural Ayurved College and Manchi Hill, Ashwi bk. Tal- Sangamner, Dist- Ahmadnagar Pin code - 413714
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975780848 |
| Fax |
|
| Email |
drkhandizod1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VD KHANDIZOD SHIVAPAL GOPALRAO |
| Designation |
PROFESSOR |
| Affiliation |
ASHWIN RURAL AYURVED COLLEGE AND HOSPITAL,MANCHI HILL, ASHWI BK. |
| Address |
OPD no-5, Shalyatantra Department, Ashwin Rural Ayurved College and Manchi Hill, Ashwi bk. Tal- Sangamner, DIST- Ahmadnagar Pin code - 413714
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975780848 |
| Fax |
|
| Email |
drkhandizod1964@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no-5, Shalyatantra Department, Ashwin Rural Ayurved College and Hospital, Manchi Hill, Ashwi bk. Tal- Sangamner, Dist - Ahmadnagar
State - Maharashtra Country - India Pin code - 413714 |
|
|
Primary Sponsor
|
| Name |
HARSHADA KANTIGIR BAWA |
| Address |
OPD no-5, Shalyatantra Department, Ashwin Rural Ayurved College and Hospital Manchi Hill, Ashwi bk. Tal- Sangamner, Dist- Ahmadnagar Pin code - 413714 |
| 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 |
| Harshada Kantigir Bawa |
Ashwin Rural Ayurved College and Hospital |
OPD no-5, Shalyatantra Department, Ashwin Rural Ayurved College and Hospital, Manchi Hill, Ashwi bk. Tal- Sangamner, Dist- Ahmadnagar Pin code - 413714
Ahmadnagar
MAHARASHTRA |
8010889565
harshadabawa39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ashvin Rural Ayurved College & Hospital Manchi Hill,Ashvi Bk,Tal-Sangamner,Dist.Ahmednagar Pin-413714 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: HINDRADYA TAILA , Reference: भै. र. ३२ , Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Taila , Reference: भै. र. २८,२९ , Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Parikartika will be taken for the study.
Patients irrespective of sex, religion, occupation & economic
status.
Patients which agreed for treatment with informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with infectious diseases like HIV/ HbsAg / HCV.
Patient with systemic diseases like Diabetes and Hypertension etc.
Patients associated with conditions like Hemorrhoids (Arsha), Fistula-in-ano (Bhagandar), Patients with Perianal abscess, rectal prolapsed and severe local sepsis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of Hinsradya Taila and Nirgundi Taila administered as Pichu in the management of Parikartika (Fissure-in-Ano), with respect to pain relief, wound healing, and reduction in associated symptoms. |
Baseline (Day 0): Prior to starting the intervention
Endline (Day 28 / Week 4): After completion of the 28-day treatment
Parameters such as pain score (VAS), bleeding, fissure healing, and patient satisfaction will be evaluated at these two points.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/08/2025 |
| 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="1"
Months="6"
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
|
To compare the efficacy of Hinsradya Taila and Nirgundi Taila administered as Pichu in the management of Parikartika (Fissure-in-Ano), with respect to pain relief, wound healing, and reduction in associated symptoms. A Total of 80 patients of fissure in ano were randomly divided into two groups. Both formulations will be administered for 28 days and outcome will be assessed. The study intend to identify which taila is better in clinical improvement contributing to more effective ayurvedic management parikartika. |