| CTRI Number |
CTRI/2025/08/093829 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO EVALUATE THE
EFFICACY OF KATUTUMBIBIJADI SUPPOSITORY & CORECT SUPPOSITORY
IN MANAGEMENT OF HEMORRHOIDS. |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE
EFFICACY OF KATUTUMBIBIJADI SUPPOSITORY & CORECT SUPPOSITORY
IN MANAGEMENT OF HEMORRHOIDS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rankhamb Vishnu |
| Designation |
Ph D Scholar shalyatantra |
| Affiliation |
PDEAS College Of Ayurved and research Centre Nigdi Pune |
| Address |
Shalyatantra Department, PDEAS College Of Ayurved and research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8624805390 |
| Fax |
|
| Email |
vishnurankhamb9999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
MS PhD Shalyatantra |
| Affiliation |
PDEAS College of Ayurveda & Research centre Nigdi Pune |
| Address |
Shalyatantra Department, PDEAS College Of Ayurved and research Centre pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
MS PhD Shalyatantra |
| Affiliation |
PDEAS College of Ayurveda & Research centre Nigdi Pune |
| Address |
Shalyatantra Department, PDEAS College Of Ayurved and research Centre pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra Department OPD 2, Sterlin Hospital, PDEAS College Of Ayurveda & Research centre Nigdi Pune Maharashtra india -411044 |
|
|
Primary Sponsor
|
| Name |
Dr Rankhamb Vishnu Hanumantrao |
| Address |
Shalyatantra Department, PDEAS College Of Ayurved and research Centre Nigdi Pune |
| 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 |
| DrRankhamb Vishnu |
Shalyatantra Department,OPD 2, PDEAS College Of Ayurveda & Research Centre |
Shalyatantra Department,OPD 2, PDEAS College Of Ayurveda & Research Centre,Akurdi, Pune, Maharashtra, India - 411044
Pune
MAHARASHTRA |
08624805390
vishnurankhamb9999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, PDEAS College Of Ayurveda & Research centre Pune |
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: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Correct Suppository , Reference: NA, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -correct suppository made by Merd Meridian | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Kututumbibijadi Suppository , Reference: NA, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Reference by Bhaishjya Ratnavali |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with first, second and third degree hameorroids.K/C/O diabetes mellitus, hypertension with concomitant therapy.
|
|
| ExclusionCriteria |
| Details |
Patients with fourth degree hemorrhoids. Associated with Fistula in ano, perianal abscess.
liver disease or C.A, immuno-compromised patient.
Patients having C.A rectum & kochs.
Rectal prolaps.
Pregnant and lactating women.
Patients with Haemoglobin below 8 gm%.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Katutumbibijadi varti is more/less effective than Corect suppository in Hemorrhoids. |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effects of Katutumbibijadi varti & of Corect suppository if any. |
4 Week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/09/2025 |
| 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
|
RANDOMIZED CONTROL CLINICAL STUDY TO EVALUATE THE EFFICACY OF KATUTUMBIBIJADI VARTI AND CORECT SUPPOSITORY IN HEMORRHOID. Sample size- 100 pt for each group Inclusion Criteria - Patients diagnosed with first,second and third degree hameorroids. Patients in the age group 18 – 50 years, irrespective of Gender, socio economic status will be taken. Exclusion Criteria - Patients with fourth degree hemorrhoids.
K/C/O diabetes mellitus, hypertension, liver disease or C.A, immune-compromised patient. Patients diagnosed with fissure in ano. Patients having C.A rectum. Pregnant and lactating women. Patients with Haemoglobin below 8 gm%.
|