| CTRI Number |
CTRI/2017/09/009744 [Registered on: 13/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
efficacy of Unani herbal formulation in the treatment of piles |
|
Scientific Title of Study
|
Efficacy of polyherbal formulation in Bawaseer (Hemorrhoids): a randomized single blind control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iqbalpatel Khanwale |
| Designation |
PG scholar |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Dept of Moalajat
Luqman Unani Medical College Hospital and Research Centre
12 Naubag
Bijapur
Bijapur
KARNATAKA
586101
India |
| Phone |
9590747736 |
| Fax |
|
| Email |
dr.iqbalpatel1689@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Iqbalpatel Khanwale |
| Designation |
PG scholar |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Dept of Moalajat
Luqman Unani Medical College Hospital and Research Centre
12 Naubag
Bijapur
KARNATAKA
586101
India |
| Phone |
9590747736 |
| Fax |
|
| Email |
dr.iqbalpatel1689@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Anzar Alam |
| Designation |
Assistant Professor |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Dept of Moalajat
Luqman Unani Medical College Hospital and Research Centre
12 Naubag
Bijapur
Bijapur
KARNATAKA
586101
India |
| Phone |
9902146030 |
| Fax |
|
| Email |
dranzarnium@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat, Luqman unani medical college hospital and research centre 12 naubag bijapur |
|
|
Primary Sponsor
|
| Name |
Luqman unani medical college hospital and research centre |
| Address |
12 Naubag Bijapur
karnataka
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Iqbalpatel Khanwale |
Luqman Unani Medical College Hospital and Research Centre |
12 Naubag
Bijapur
KARNATAKA |
9590747736
9595747736
dr.iqbalpatel1689@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 |
Bawaseer (Haemorrhoids), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hamdoroid Capsule |
2 Capsule BD for 30 days orally |
| Intervention |
polyherbal unani formulation |
1 Habb of 500mg BD for 30 days orally |
|
|
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 (Grades Ι & П) confirmed by proctoscopy |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from systemic diseases and severe anaemia.
2.Hemorrhoids with fistula in anal canal confirmed by proctoscopic examination.
3.Pregnancy and lactation.
4.Patients currently using other anti-hemorrhoid drugs.
5.Female patients with menstrual disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in subjective and objective parameters |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Hb% |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2016 |
| Date of Study Completion (India) |
30/04/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
30 diagnosed cases of Bawaseer (Hemorrhoids) will be randomly allocated either to test (n=15) or control group (n=15). Patients will be blinded for the study. In the test group; 500mg hab of the polyherbal formulation will be give morning and evening for 30 days orally. In the control drug 2 Capsule Hamdoroid will be given orally morning and evening for 30 days.The follow up of patients will be done at 15 days interval. Two follow up during treatment and two after treatment will be done. Assessment of subjective parameters will be done on each visit and objective parameters will be assessed before and after treatment. |