| CTRI Number |
CTRI/2025/02/080181 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study Of Siktha Haridradi Malahar (Ointment) In The Management Of Parikartika W.S.R. To Fissure In Ano |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study Of Siktha Haridradi Malahar (Ointment) In The Management Of 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. SHRINIVAS SHANKAR IRABATI |
| Designation |
PHD SCHOLAR |
| Affiliation |
R A PODDAR AYURVED MEDICAL COLLEGE |
| Address |
R A PODDAR MEDICAL COLLEGE DEPARTMENT OF SHALYATANTRA OPD NO 5 GROUND FLOOR WORLI MUMBAI
Mumbai
MAHARASHTRA
400018
India |
| Phone |
09892905860 |
| Fax |
|
| Email |
dr.shrinivasirabatti@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD RAJESHWAR REDDY |
| Designation |
PROFESSOR |
| Affiliation |
R A PODDAR AYURVED MEDICAL COLLEGE |
| Address |
R A PODDAR MEDICAL COLLEGE DEPARTMENT OF SHALYATANTRA OPD NO 5 GROUND FLOOR WORLI MUMBAI
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9820864287 |
| Fax |
|
| Email |
reddyrajeshwar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VD RAJESHWAR REDDY |
| Designation |
PROFESSOR |
| Affiliation |
R A PODDAR AYURVED MEDICAL COLLEGE |
| Address |
R A PODAR AYURVED MEDICAL COLLEGE DEPARTMENT OF SHALYATANTRA OPD NO 5 GROUND FLOOR DR ANNIE BESANT ROAD WORLI MUMBAI
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9820864287 |
| Fax |
|
| Email |
reddyrajeshwar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| R A PODAR AYURVED MEDICAL COLLEGE DR ANNIE BESANT ROAD WORLI MUMBAI MAHARASHTRA 400018 |
|
|
Primary Sponsor
|
| Name |
DR SHRINIVAS IRABATI |
| Address |
SHRI SIDDHIVINAYAK CLINIC SHOP NO 5 GIRATH BLDG NEAR JAIN DUGDHALAY CARTER ROAD NO 3 BORIVALI EAST MUMBAI 400066 |
| 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 SHRINIVAS SHANKAR IRABATTI |
RA PODAR AYURVED MEDICAL COLLEGE |
DEPARTMENT OF SHAILYATANTRA OPD NO 5 GROUNF FLOOR DR ANNIE BESANT ROAD WORLI MUMBAI
Mumbai
MAHARASHTRA |
9892905860
dr.shrinivasirabatti@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE RA PODAR AYURVED COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | NEFIDIPINE AND LIDOCAINE OINTMENT | ANAL APPLICATION TWICE A DAY FOR 15 DAYS | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Siktha Haridradi Malahar, Reference: NA, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Medicine and Procedure reference from Rasatarangini 2/34 and we added some extra Vranaropana Dravyas |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from acute and chronic fissue in ano with presenting sign and symptoms eg pain anal spasm and per rectal bleeding burning sensation in ano constipation. Pregnant and lactating female. Patients having fissure in ano along with first and second degree hemorrhoids. Patients having controlled diabetes mellitus hypertension on medication |
|
| ExclusionCriteria |
| Details |
Patients who are having systemic disease and immune compromised disease. Patients who are having carcinoma of anus and rectum proctalgia fugax ulcerative collitis crohns disease fistula in ano perianal abscess and any other major illness. Patients having hemoglobin less than 9 gm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in the effect of trial drug in parikartika subjective criterias are pain
Anal ulcer
Burning sensation
Constipation
Objective criterias are
Spasm (resting pressure)
Above parameters are assessed before and after treatment
|
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN SYMPTOMS OF PARIKARTIKA |
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
15/02/2025 |
| 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 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
|
ANAL FISSURE COMPRISES OF AN ALARMING INCIDENCE RATE OF 12-15% AMONG DIFFERENT PROCTOLOGICAL PATHOLOGIES THIS ALWAYS POINTS TOWARDS NEW FORMULATION TO MANAGE THE DISEASE EFFECTIVELY HENCE SIKTHA HARIDRADI MALAHAR MENTIONED FOR PARIKARTIKA DISEASE IN RASATARANGINI 2/34 WE ARE ALSO ADDING SOME VRANAROPAN DRUGS AND PREPARE OWN SIKTHA HARIDRADI MALAHAR IN THE MANAGEMENT OF PARIKARTIKA |