| CTRI Number |
CTRI/2018/08/015373 [Registered on: 17/08/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Non bleeding piles with Unani Medicine Habb-e-Bawaseer Amya. |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Habb-e-Bawaseer Amya in Bawaseer Amya (Non bleeding piles) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BD/NBP/HBD/CLN-VAL/CCRUM 16-17 version 1, 26.03.17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 507
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
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 507
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 (Path) SIV |
| 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@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine Mumbai 2. Regional Research Institute of Unani Medicine Chennai 3 Regional Research Centre Allahabad Monetary 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 110058 |
|
|
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 South West DELHI 110058 India |
| 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 Ashok Kumar |
Regional Research Centre |
Research OPD Room Bawaseer Amya (Non bleeding piles)
B-501/4, G T B Nagar (Opposite Dulhan Palace)
Allahabad
UTTAR PRADESH |
9450619024
rrcallahabad@gmail.com |
| Dr Irfan Ahmad |
Regional Research Institute of Unani Medicine |
Research OPD Room Bawaseer Amya (Non bleeding piles)
Behind Eye Bank, Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
9987427379
irfanmumbai8@gmail.com |
| Dr Mrs T Shahida Begum |
Regional Research Institute of Unani Medicine |
Research OPD Room Bawaseer Amya (Non bleeding piles)
1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU |
04425955519
tshahidabegum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Centre Allahabad |
Approved |
| Regional Research Institute of Unani Medicine Chennai |
Approved |
| Regional Research Institute of Unani Medicine Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bawaseer Amya (Non bleeding piles), (1) ICD-10 Condition: K640||First degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Bawaseer Umiyya |
Habb-e-Bawaseer Umiyya, 1 Pill (250 mg ) orally Twice daily with water one hour after meals for two weeks
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group 18 to 65 years
2. Patients diagnosed with BawÄsÄ«r Umiyya (Non-bleeding Piles) presenting with any of the following symptoms:
(i) Mucoid Anal/ Perianal Discharge (SayalÄn al-Maq‘ad MukhÄtÄ«): mucus discharge
(ii) Pruritus Ani (Hikka al-Maq‘ad)
(iii) Mucosal Prolapse (KhurÅ«j al-MukhÄtÄ«yya) with Spontaneous Reduction
(iv) Rectal/ Anal Pain (Waja‘ al-Maq‘ad)
|
|
| ExclusionCriteria |
| Details |
The following patients will be excluded from the study:
1. Patients with Bawaseer Damiya (Bleeding piles).
2. Patients with Fourth Degree Haemorrhoids (irreducible prolapse)
3. Known cases of Anal fissure, anal fistula and other surgical conditions of the anus.
4. Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc)
5. Patients with Inflammatory Bowel Disorders (Positive Haemoccult Test)
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 Bawaseer Amya (Non bleeding piles) |
Two Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Two weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 2 |
|
Date of First Enrollment (India)
|
21/08/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
his study is a multicentric open trial in patients with Bawaseer Amya (Non bleeding piles) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline,and after two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be fourteen days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapyComposition of Habb-e-Bawaseer Damiya (Anonymous, 2006) | S. No. | Ingredients | Botanical / English Name | Quantity | -
| Rasaut | Berberis aristata DC. | 100 g | -
| Halela Kabli Biryan | Terminalia chebula Retz. | 100 g | -
| Raughan Zard | Cow’s Ghee | Q.S. | |