| CTRI Number |
CTRI/2023/01/048911 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [THERAPEUTIC] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial to compare Yashtyadi Malahara with Nifedipine Ointment in fissure in ano |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial to compare Yashtyadi Malahara with Nifedipine Ointment as a local intervention in Parikartika(Fissure in ano ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Mahendra Upadhyay |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Shalya tantra department, Tilak Ayurved Mahavidyalaya ,Rastapeth ,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9029405166 |
| Fax |
|
| Email |
Nehajk151@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandkishor V Borse |
| Designation |
Professor and HOD, Shalya tantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya ,Pune |
| Address |
Tilak Ayurved Mahavidyalaya, rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
drnvborse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandkishor V Borse |
| Designation |
Professor and HOD, Shalya tantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya ,pune |
| Address |
Tilak Ayurved Mahavidyalaya, rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
drnvborse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya , rasta peth , Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya , Rasta Peth ,Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Seth Tarachand Ramnath Charitable Ayurved Hospital |
Rasta Peth ,Pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr NEHA MAHENDRA UPADHYAY |
Seth Tarachand Ramnath Charitable Ayurved Hospital |
Shalya tantra opd no. 7 , ground floor, Tarachand hospital, rasta peth , Pune
Pune
MAHARASHTRA |
9029405166
nehajk151@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: siddhya yoga sangraha pratham pru 849, Procedure details: Local application of yashtyadi malahara for 20days every 8hrly after giving warm water sitz bath for period of 15minutes .)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Nifedipine Ointment | local application of nifedipine ointment for 20days every 8hrly |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 All the clinically diagnosed patients of parikartika |
|
| ExclusionCriteria |
| Details |
1 Uncontrolled systemic diseases
2 Known case of CA Rectum
3 Severely immunocompromised
4 Patients having parikartika secondary to ulcerative colitis , syphilis , chrons disease ,TB |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain ,
Healing of wound at anal verge ( tear ) will be assessed |
Baseline , day 1st , 7th , 14th , 20th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rakta strava ( Pr Bleeding) assessment |
After 20days |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2023 |
| 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
|
not yet published |
|
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 common and increasing in incidence . In consideration of severity of symptoms of fissure in ano , one needs to advocate treatment with suitable medications which is cost effective and easily available and more potent to relieve the pain and spasm . For this purpose yashti and tila kalka is taken as a trial drug. Interventional drug is administered with primary outcome of pain management and wound healing in fissure in ano . local application of malahara will be done for period of 20days along with sitz bath . |