| CTRI Number |
CTRI/2017/10/010038 [Registered on: 06/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A multi-centre study to compare and evaluate a herbal capsule in patients with hemorrhoids |
|
Scientific Title of Study
|
A multi-centric, randomised, comparative, clinical study for evaluation of herbal capsule in patients suffering from hemorrhoids |
| Trial Acronym |
HILO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/OH/10/2016 Version no.01 Version date 15/11/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director- Medical Services |
| Affiliation |
Zuventus Healthcare Limited |
| Address |
Office No. 5119, 5th Floor,
D-Wing, Oberoi Garden Estates,
Chandivali, Andheri (E), Mumbai 400072
Mumbai
MAHARASHTRA
400072
India |
| Phone |
022-30610000 |
| Fax |
022-28472829 |
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director- Medical Services |
| Affiliation |
Zuventus Healthcare Limited |
| Address |
Office No. 5119, 5th Floor,
D-Wing, Oberoi Garden Estates,
Chandivali, Andheri (E), Mumbai 400072
Mumbai
MAHARASHTRA
400072
India |
| Phone |
022-30610000 |
| Fax |
022-28472829 |
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director- Medical Services |
| Affiliation |
Zuventus Healthcare Limited |
| Address |
Office No. 5119, 5th Floor,
D-Wing, Oberoi Garden Estates,
Chandivali, Andheri (E), Mumbai 400072
Mumbai
MAHARASHTRA
400072
India |
| Phone |
022-30610000 |
| Fax |
022-28472829 |
| Email |
bhupesh.dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
| ZUVENTUS HEALTHCARE LIMITED
Oberoi Garden Estates,
Chandivali, Andheri (E), Mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Limited |
| Address |
Zuventus Healthcare Limited
Oberoi Garden Estates,
Chandivali, Andheri (E), Mumbai 400072
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Bhaskar |
Janta Hospital And Maternity Centre |
1st floor, Janta Hospital And Maternity Centre
Malti Bagh, Tilbhandeshwer, Bhelupur, Varanasi, Uttar Pradesh 221001
Varanasi
UTTAR PRADESH |
9580210470
dramitbhaskar@gmail.com |
| Dr Ajay Kumar |
King Georges Medical University, Lucknow |
Department Of Gastroenterology, King Georges Medical University
Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
9532701744
drajaymd12345@gmail.com |
| Dr Santosh Saklecha |
Santosh Hospital |
6/1, Promenade Road, Behind Coles park, Near Goodwill School
Bangalore
KARNATAKA |
9845306703
ssaklehcha@gmail.com |
| Dr Sujit Kadam |
Vijan hospital and research centre |
Flat no 2,Sarth clinic, opp Vijan hospital and research centre, college road, nashik,422005
Nashik
MAHARASHTRA |
9021196767
drsujitkadam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Janta Hospital Ethics Committee |
Approved |
| King George Medical University Institutional Ethics Committee |
Approved |
| Santosh Hospital Institutional Ethics Committee |
Approved |
| Vijan Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
daflon 500mg |
Fixed dose combination of
Diosmin 450 mg
Hesperidin 50 mg
2 tablets daily in 2 divided doses, mid-day and evening after meals
|
| Intervention |
Herbal Capsule (HILO)
|
Fixed dose combination
Commiphora molmol 250 mg
Gardenia gummifera 83 mg
Tagetes erecta 83.5 mg
Mesua ferrea 83.5 mg
2 capsules twice daily with water for 15 days preferably after meals
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender, aged ≥18 years, with hemorrhoids confirmed by proctoscopy
2.Patients able to give signed informed consent before examination.
|
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity to any of the ingredients of the formulation
2.Patients currently using other antihemorrhoidal drugs or planning to undergo any surgical procedure for hemorrhoids
3.Pregnant women, or lactating mothers
4.Patients otherwise judged to be inappropriate for inclusion in the study by the investigator
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the efficacy of herbal capsules (HILO) compared to Daflon in patients with Hemorrhoids. |
Proportion of patients showing improvement in clinical symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety of the investigational product in Indian patients
|
Proportion of patients reporting adverse events |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/05/2017 |
| Date of Study Completion (India) |
28/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Dewan B, Prabhu S. Evaluation of Hilo® Versus Daflon® in Patients Suffering from Hemorrhoids: A Randomized, Controlled, Open-labelled, Multicentric Study. Journal of Advances in Medicine and Medical Research. 2019 Aug 23:1-2. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Hemorrhoids are a very common anorectal condition affecting millions of people worldwide. Low compliance associated with non-pharmacological treatment along with adverse effects or complications associated with other therapeutic modalities renders use of herbal medicines as an important therapeutic option for management and treatment of hemorrhoids.
The present study is conducted to compare the efficacy and safety of herbal medicines Hilo and Daflon, the treatment of hemorrhoids.
Primary study objective is to assess the efficacy of herbal capsule (HILOTM) compared to Daflon in patients diagnosed with Hemorrhoids. Secondary objectives : 1. Global assessment of efficacy by investigators and patients. 2. To evaluate the safety of the investigational drug in Indian patients.
|