| CTRI Number |
CTRI/2023/06/053991 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to compare bahubeeja ointment with nifedipine ointment in fissure in ano |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare bahubeeja malhara 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 Dnyaneshwar Pathade |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyala |
| Address |
Shalya tantra department,Tilak ayurved Mahavidyalaya,Rasta Peth,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9604635017 |
| Fax |
|
| Email |
dpathade7302@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandkishor Borse |
| Designation |
Professor and HOD shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyala |
| Address |
Shalya Tantra department,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 Dnyaneshwar Pathade |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyala |
| Address |
Shalya Tantra department,Tilak ayurved mahavidyalaya,rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9604635017 |
| Fax |
|
| Email |
dpathade7302@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyala rasta peth pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,Rasta peth Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Seth tarachand ramnath 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 Dnyaneshwar Pathade |
Seth Tarachand Ramnath Ayurvedic Hospital |
Tilak ayurved mahavidyala deptartment of shalyatantra surgery OPD no.7 rasta peth pune
Pune
MAHARASHTRA |
9604635017
dpathade7302@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee tilak ayurved mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: Anal fissure,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bahubeej malahar |
Route of administration- Local
Frequency- 7 days application
Total duration -21 days |
| Comparator Agent |
Nefedepin ointment |
Route of administration -Local
Frequency - 7days application
Total duration -21days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all clinically diagnosed patients of parikartika |
|
| ExclusionCriteria |
| Details |
Uncontrolled systemic disease
Known case of CA rectum
Severely immunocompromised
Patient having parikartika secondary to ulcerative collitis,syphilis,TB |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of pain
Healing of wound at anal verge(tear) will be assessed |
Baseline,day 1st,7th,14th,21st |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Raktastrav(PR bleeding) assessment |
after 21 days |
|
|
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)
|
07/07/2023 |
| 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 disorder are common and increasing in incidence. Inconsideration of severity of symptoms of fissure in ano,one need to advocate treatment with suitable medication which is cost effective and easily available and more potent to relieve the pain and spasm. For this purpose bahubeej kalka and sikta is taken as trial drug. Interventional drug is administered with primary outcome of pain management and wound healing in fissure in ano. Local application of malahar will be done for a period of 21 days along with sitz bath. |