| CTRI Number |
CTRI/2013/01/003329 [Registered on: 28/01/2013] Trial Registered Prospectively |
| Last Modified On: |
24/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of ARWL12 Capsule in Patients suffering from Internal Hemorrhoids |
|
Scientific Title of Study
|
An Open Labeled, Single Centre, Prospective, Clinical Study to Evaluate Efficacy and Safety of ARWL12 Capsule in Patients suffering from Internal Hemorrhoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARWL12/HE/01/2012, Version 1, 5th November 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Padmakarrao Ukhalkar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital Vazirabad Nanded |
| Address |
Shalyatantra Department Government Ayurved College and Hospital Vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
02462234026 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research 205 B Wing Blue Diamond Society Nayagoan, Dahisar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
02228913701 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavana Zalavadiya |
| Designation |
Clinical Trial Manager |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research 205 B Wing Blue Diamond Society Nayagoan, Dahisar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
8080931975 |
| Fax |
|
| Email |
targetinst1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Welex Laboratories Pvt. Ltd.
120, T.V. Industrial Estate,
248/A, S.K. Ahire Marg,
Worli, Mumbai-400 025
Tel: 022-66150225, 66150226
Email: welex@vsnl.com
|
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
120, T.V. Industrial Estate, 248/A, S.K. Ahire Marg, Worli, Mumbai-400 025 Tel: 022-66150225, 66150226 Email: welex@vsnl.com |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vijay Padmakarrao Ukhalkar |
Shlyatantra Department |
Government Ayurved College and Hospital Vazirabad Nanded
Nanded
MAHARASHTRA |
02462234026
ukhalkarvp@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurved College and Hospital Vazirabad Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Internal Hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARWL12 Capsule |
Each Capsule contains:
Laiwanti Extract (Mimosa pudica), Nilophar (Nymphae raubra), Neem beei Extract (Azadirachta indica), Suran (Amorphophlauls campanautlus), lsabgol (Plantago ovata), Sal (Shorea robusta), Dhania Extract (Coniandrum sativum), Harde Extract (Terminalia chebula), Avla Extract (Emblica officinalis), Nagkeshar (Mesua ferrea), Raktabol (Commiphora myrrha), Kutaj (Holarrhena antidysenterica), Mochras (Salmalia malabarica), Beal Phal (Aegle marmelos), Karanj (Caesalpinia crista)
Dosage and Treatment Duration:
Two capsules twice daily orally after meals for 60 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Literate males or non-pregnant females, aged 20 to 60 years (both inclusive).
2.Symptomatic internal hemorrhoids, Grades I & II by direct proctoscopic visualization
3.Bleeding from hemorrhoids for at least two days prior to randomization
4.Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
5.Subjects of female gender or non-pregnant, non-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
6.Females of child bearing potential who agree to use contraception.
7.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1.Patients with protruding or irreducible hemorrhoids (grade IV).
2.Patients with anal fistulas, periproctitis or hemorrhagic diathesis
3.Patients with current history of Type I or Type II diabetes mellitus.
4.Patients with severe hepatic, renal or cardiovascular disorders.
5.Patients with any type of infectious disease.
6.Patients who have been involved with another experimental drug trial within the past 30 days.
7.Patients presently diagnosed with cancer.
8.Patients who have known alcohol and drug abuse.
9.Patients who require the use of suppositories.
10.Use of anticoagulants within 30 days prior to Day 1.
11.Patients on anti-platelet agents or low dose aspirin
12.Use of over the counter or prescription anti-hemorrhoid agents (allopathic, herbal, homeopathic, Unani, Siddha medicines) within 14 days prior to Day 1.
13.Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
14.Known hypersensitivity to ingredients used in study drug
15.Pregnant and Lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of subjects achieving cessation of per rectal bleeding at the end of the treatment
2. Post treatment reduction in severity of bleeding per rectum
|
2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Post treatment reduction in pile mass
2.Post treatment reduction in other symptoms of hemorrhoids
3.Improvement in Quality of Life at the end of the treatment
4.Global assessment for overall improvement by patient at the end of the treatment
5.Global assessment for overall improvement by physician at the end of the treatment
6.Assessment of pre and post treatment changes in laboratory investigations like LFT RFT Lipid profile CBC ESR Urine Examination Stool Examination and ECG. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open labeled,
single centre, prospective, clinical study to evaluate efficacy and safety of
ARWL12 capsule in patients suffering from Internal Hemorrhoids. Subjects will
be advised to take 2 capsules twice daily after meals for 60 days. The study
will be carried out in Government Ayurved College and Hospital, Vazirabad,
Nanded, India. The study will be carried out in 38 patients of Internal
Hemorrhoids. Primary objectives will be to observe proportion of subjects
achieving cessation of per rectal bleeding at the end of the treatment and post
treatment reduction in severity of bleeding per rectum. Secondary objectives
will be to observe post treatment reduction in pile mass, post treatment
reduction in other symptoms of hemorrhoids, improvement in Quality of Life at
the end of the treatment, Global assessment for overall improvement by patient
at the end of the treatment, Global assessment for overall improvement by
physician at the end of the treatment and assessment of pre and post treatment
changes in laboratory investigations like Liver function tests (LFT), Renal
function tests (RFT), Lipid profile, Complete Blood Count (CBC), ESR, Urine
Examination, Stool Examination and ECG. |