| CTRI Number |
CTRI/2025/09/094079 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effectiveness and Safety of SMUTHTM Capsule in the treatment of patients with Piles. |
|
Scientific Title of Study
|
A Prospective Randomized Double blind Comparative Multicentre Phase IV Clinical Trial to evaluate the Efficacy and Safety of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg Docusate Sodium IP 100 mg in comparison with Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AZ-C-ZIR-19-111, Version 03, 25/12/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Maladkar |
| Designation |
President Medical and Regulatory affairs |
| Affiliation |
Aristo Pharmaceuticals Private Limited |
| Address |
Aristo Pharmaceuticals Private Limited 23 A Shah Industrial Estate off Veera Desai road Andheri west
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
02226739999 |
| Fax |
|
| Email |
scientific@aristopharma.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Patil |
| Designation |
Senior DGM Medical |
| Affiliation |
Aristo Pharmaceuticals Private Limited |
| Address |
Aristo Pharmaceuticals Private Limited 23 A Shah Industrial Estate off Veera Desai road Andheri west
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
02226739999 |
| Fax |
|
| Email |
aepvc.scientific@aristopharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahendra Chaudhari |
| Designation |
HOD Clinical Research |
| Affiliation |
Anazeal Analyticals and research private limited. |
| Address |
Anazeal Analticals and research Private Limited C 404 ttc Industrial area opp JISL MIDC Pawane Navi mumbai
Thane
MAHARASHTRA
400705
India |
| Phone |
02269060300 |
| Fax |
|
| Email |
ct1@anazeal.com |
|
|
Source of Monetary or Material Support
|
| Aristo Pharmaceuticals Private Limited. 23 A shah Industrial estate off veera desai road Andheri west Mumbai 400053 Maharashtra India.
|
|
|
Primary Sponsor
|
| Name |
Aristo Pharmaceuticals Private Limited |
| Address |
23 A Shah Industrial Estate off Veera Desai road Andheri west Mumbai 400053 Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khillari Madhu |
Government Medical college and govt. General Hospital |
Government Medical college and govt General Hospital Srikakulam Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH |
9912320517
bioexperts21@gmail.com |
| Dr Manish Kumar Singh |
Heal U Health Care Hospital |
Baghdulhan Vishnupur Paltu Hajipur Bihar 844101
Patna
BIHAR |
8960197793
Heal.u.hospital@gmail.com |
| Dr Shiv Kumar Bunkar |
JLN Medical college |
Department of Surgery Jawahar Lal Nehru Medical College and Hospital Kala Bagh Ajmer 305001 Rajasthan India
Ajmer
RAJASTHAN |
7737258659
kkcrc90@gmail.com |
| Dr Vijaykumar Barge |
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital |
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital Town Hall Kolhapur 416012
Kolhapur
MAHARASHTRA |
7969792775
drvijaybarge12@gmail.com |
| Dr Vivekanand Rai |
Sai Medicity Pvt Ltd Hospital |
Varanasi Uttar Pradesh221005 India
Varanasi
UTTAR PRADESH |
9455272710
smplvns@gmail.com |
| Dr Sujit Kadam |
Sarth Clinic and Research Center |
Department of Medicine Sarth Clinic and Research Center College Road Nashik 422005
Nashik
MAHARASHTRA |
9326808994
drsujitkadam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee of Sai Medicity Pvt.Ltd Sai Medicity Pvt.Ltd |
Approved |
| Institutional Ethics Committee Govt Medical College Govt General Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Jawahar Lal Nehru Medical College |
Approved |
| Muktai Hospital Institutional Ethics Committee. |
Approved |
| RCSMGMCIEC2 RCSMGMC and CPR Hospital , Kolhapur |
Approved |
| Savera Cancer and Multispecialty Hospital IEC, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DOBESIL Capsule |
Calcium Dobesilate 500 mg
Dose One capsule TDS orally per day
Duration 35 days |
| Intervention |
SMUTH Capsule |
Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg plus Docusate Sodium IP 100 mg
Dose One capsule TDS orally per day
Duration 35 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between 18 and 65 years of age (inclusive of both).
2. Adult patients with 1° or 2° haemorrhoids diagnosed by clinical symptoms and anoscopy examination.
3. Haemorrhoids that bleed but do not prolapse outside the anal canal. |
|
| ExclusionCriteria |
| Details |
1. Patients with 3° or 4° haemorrhoids, in whom the prolapse needed manual reduction or cannot be reduced.
2. Concurrent fistula or chronic anal fissure, inflammatory bowel disease, diabetes, coagulation disorders, abnormal sexual habits.
3. Previous anorectal surgery or previous treatment of haemorrhoid disease with any method other than diet modification and/or topical agents.
4. Clinically significant abnormalities on physical examination or laboratory tests.
5. Pregnant and lactating women.
6. Patients having known hypersensitivity to the study medications and/or ingredients in capsule.
7. Not willing to comply with the protocol requirements.
8. Non-suitability for enrollment otherwise as decided by investigator.
9. Patients having participated in any type of clinical study within the last three months of the screening date. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids. |
Visit 1 Day 0 Baseline visit
follow up at Visit 2 Day 7, Visit 3 Day 14, Visit 4 Day 21, Visit 5 Day 28 and Visit 6 Day 35 end of study.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg Plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids. |
Visit 1 Day 0 Baseline visit
follow up at Visit 2 Day 7, Visit 3 Day 14, Visit 4 Day 21, Visit 5 Day 28 & Visit 6 Day 35 end of study.
|
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Study Title - A Prospective, Randomized, Double blind, Comparative, Multicentre, Phase IV Clinical Trial to evaluate the Efficacy and Safety of SMUTHTM Capsule (Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg + Docusate Sodium IP 100 mg) in comparison with Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.
Investigational Product - Test Product: SMUTHTM Capsule(Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg + Docusate Sodium IP 100 mg) Reference Product: Dobesil 500mg Capsule (Calcium Dobesilate 500 mg). Treatment Duration - 35 days Study Endpoints - Efficacy: 1. Improvement in the following clinical symptoms from baseline to visit 6 Bleeding per rectum Anal pain Anal discomfort Anal pruritus Tenesmus Constipation/irregular bowel habits 2. Anoscopy examination assessment (Anitis score) visit 1(Day 0), visit 3(3rdweek), visit 6(6th week). 3. Global assessment of efficacy by the Investigator and Patient. Safety : 1. 1. Any adverse event reported voluntarily, observed or enquired during the study period based on the evaluation of the following: Adverse Event (type, number, frequency and proportion of patients) Concomitant medication. 2. 2. Any clinically significant change in the value of laboratory tests, vital signs and physical examination findings during the study compared to baseline. 3. 3. Global assessment of safety by Investigator and Patient.
|