| CTRI Number |
CTRI/2018/10/016190 [Registered on: 29/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Unani medicine Habb-e-Bawaseer Damiya in Bleeding Piles |
|
Scientific Title of Study
|
Clinical Validation of a Unani Pharmacopoeial formulation – Habb-e-Bawaseer Damiya in BawÄsÄ«r DÄmiya (Bleeding Piles) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BD/BP/HBD/CLN-VAL/CCRUM 15-16 Version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director Gernal |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer Scientist III |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 516
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jawadul Haq |
Clinical Research Unit |
Research OPD 1
40/23 Park Road
Kurnool
ANDHRA PRADESH |
09542443555
cru.kurnool@gmail.com |
| Dr Mohammad Zakir |
Regional Research Institute of Unani Medicine |
Research OPD 1
Chanderbali By Pass Road
Bhadrak
ORISSA |
09010374465
urzakir@rediffmail.com |
| Dr Yunis Munshi |
Regional Research Institute of Unani Medicine |
Research OPD Mo 2, 79 Chittaranjan Avenue
Kolkata
WEST BENGAL |
09419086700
younismunshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Bhadrak |
Approved |
| Regional Research Institute of Unani Medicine, Kolkata |
Submittted/Under Review |
| Clinical Research Unit, Kurnool |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
BawÄsÄ«r DÄmiya (Bleeding Piles), (1) ICD-10 Condition: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Bawaseer Damiya ( 259 mg) |
1 tablet orally once daily with water one hour after meals for two weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any sex in the age group 19 to 65 years
2. Patients with a diagnosis of First and Second Degree Hemorrhoids presenting with any of the following symptoms:
3.Bleeding Per Rectum (JarayÄn al-Dam fi’l Maq‘ad): bright-red, painless bleeding
4. Mucoid Anal/ Perianal Discharge (SayalÄn al-Maq‘ad MukhÄtÄ«): mucus discharge
5. Pruritus Ani (Hikka al-Maq‘ad)
6. Mucosal Prolapse (KhurÅ«j al-MukhÄtÄ«yya) with Spontaneous Reduction
7. Rectal/ Anal Pain (Waja‘ al-Maq‘ad): on prolapse
|
|
| ExclusionCriteria |
| Details |
1. Third & Fourth Degree Haemorrhoids, anal fissure, anal fistula, IBD, Diabetes Mellitus
2. Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study
3. Patients with laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator
4. Known hypersensitivity to study drug or any of its ingredients
5. History of alcohol and drug abuse
6. Pregnant and Lactating Women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of BawÄsÄ«r DÄmiya (Bleeding Piles) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and after two weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2016 |
| Date of Study Completion (India) |
14/02/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric open trial in patients with BawÄsÄ«r DÄmiya (Bleeding Piles) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline and of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Habb-e-Bawaseer Damiya (Anonymous,
2006)
|
S. No.
|
Ingredients
|
Botanical / English Name
|
Quantity
|
|
1.
|
Muqil
|
Commiphora
mukul (Hook. ex
Stocks) Engl.
|
30 g
|
|
2.
|
Rasaut
|
Berberis
aristata DC.
|
10 g
|
|
3.
|
Kahruba
|
Pinus
succinifera Linn.
|
5 g
|
|
4.
|
Dana Heel
Khurd
|
Elettaria
cardamomum (Linn.)
Maton
|
5 g
|
|
5.
|
Damm-ul-Akhwain
|
Dracaena
cinnabari Balf.f.
|
5 g
|
|
6.
|
Halela
Siyah Biryan
|
Terminalia
chebula Retz.
|
5 g
|
|
7.
|
Amla
Khushk
|
Phyllanthus
emblica Linn.
|
5 g
|
|
8.
|
Tabasheer
|
Bambusa
arundinacea (Retz.)
Roxb.
|
5 g
|
|
9.
|
Gil-e-Armani
|
Armenian
Bole
|
5 g
|
|
10.
|
Aab-e-Gandana
|
Asphodelus
tenuifolius
Cav.
|
Q.S.
|
|
11.
|
Raughan
Zard
|
Cow’s
Ghee
|
Q.S.
|
|