| CTRI Number |
CTRI/2013/10/004069 [Registered on: 17/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Hemorrhoids with Unani formulations Habbe Rasuat, Habb-e- Muqil, Habb-e- Papita and Marham e Saeeda Chob Neem Wala. |
|
Scientific Title of Study
|
Validation of Unani Pharmacopoeial formulations in Bawaseer-E-Damiya (Piles) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ABDUL HANNAN |
| Designation |
Joint Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058.
New Delhi
DELHI
110058
India |
| Phone |
011-28522965 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABDUL HANNAN |
| Designation |
Joint Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058.
DELHI
110058
India |
| Phone |
011-28522965 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABDUL HANNAN |
| Designation |
Joint Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058.
DELHI
110058
India |
| Phone |
011-28522965 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support :
1 Regional Research Institute of Unani Medicine (RRIUM), Bhadrak
2. Regional Research Institute of Unani Medicine(RRIUM), New Delhi
3. Regional Research Institute of Unani Medicine(RRIUM), Kolkata
Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Central Council for Research in Unani Medicine(CCRUM), 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 RASHIDULLAH KHAN |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25
New Delhi
DELHI |
01126952759
01126952759
rriumdelhi@gmail.com |
| Dr Qamaruddin |
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak |
Motel Chhak, Mathasahi, Bhadrak-756100 (Odisha)
Bhadrak
ORISSA |
06784240289
06784240660
rriumbdk_unani@yahoo.co.in |
| DR IRSHAD AHMAD KHAN |
Regional Research Institute of Unani Medicine (RRIUM), Kolkata |
79, CHITRANJAN AVENUE, KOLKATA
Kolkata
WEST BENGAL |
03322372107
03322372107
rrium_kol@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| RRIUM BHADRAK INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| RRIUM KOLKOTA INSTITUTIONAL ETHICS COMMITTEE |
Submittted/Under Review |
| RRIUM NEW DELHI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
BAWASEER-E-DAMIYA (Hemorrhoids), (1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Habb-e-Rasaut,
2.Habb-e-Muqil,
3.Majoon Muqil,
Marham Saeeda Chob Neem Wala,
|
1.Habb-e-Rasaut One pill Orally two times daily with water.
2. Habb-e-Muqil, One pill two times daily Orally,with water.
3. Majoon Muqil,5 gms Orally once daily
4. Marham Saeeda Chob Neem Wala ointment, local application once daily
Duration of Treatment: 6 weeks |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients of either sex in the age group of 18 to 65 years
2. Patients having the following symptoms and signs of the disease
• Rectal Bleeding
• First and Second Degree Hemorrhoids
• Pruritus Ani
• Rectal and Anal Pain
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 65 years of age
2. Patients with Third and Fourth Degree Haemorrhoids
3. Patients with Anal fissures
4. Patients with other long term diseases/ disorders
5. Malnourished Patients (BMI of 18.5 kg/m2 and Haemoglobin 12 g/dL)
6. Patients with Inflammatory Bowel Disease(Ulcerative colitis, Crohn,s disease etc).
7. 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 |
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HAEMATOLOGICAL AND BIOCHEMICAL ASSESMENT OF LABORATORY PARAMETERS |
6 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)
|
02/11/2011 |
| 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) |
Open to Recruitment |
|
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 BAWASEER-E-DAMIYA (Hemorrhoids). After screening, Patients will be enrolled if they satisfy following inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 6 weeks and the follow-up for all clinical parameters will be conducted every two weeks. Laboratory parameters for safety assessment will be conducted at baseline and end of study.
Bawaseer e Damia
|
Habb-e-Rasaut
|
|
S.No
|
Name
|
Quantity
|
|
1
|
Rasaut
|
50 g.
|
|
2
|
Kateera
|
20 g.
|
|
3
|
Mazu
|
10 g.
|
|
4
|
Sang-e-Jarahat
|
10 g.
|
|
5
|
Geru
|
10 g.
|
|
Majoon-e-Muqil
|
|
S.No
|
Name
|
Quantity
|
|
1
|
Post-e-Halela Kabli
|
10 g.
|
|
2
|
Post-e-Balela
|
10 g.
|
|
3
|
Aamla
|
10 g.
|
|
4
|
Dana Heel Khurd
|
10 g.
|
|
5
|
Badiyan
|
10 g.
|
|
6
|
Nankhwah
|
5 g.
|
|
7
|
Sazaj Hindi
|
5 g.
|
|
8
|
Narmushk
|
5 g.
|
|
9
|
Zanjabeel
|
5 g.
|
|
10
|
Satar Farsi
|
5 g.
|
|
11
|
Waj-e-Turki
|
5 g.
|
|
12
|
Filfil Daraz
|
5 g.
|
|
13
|
Muqil
|
85 g.
|
|
14
|
Asal OR Qand Safaid
|
350 g.
|
Habb
e Muqil
|
S.No
|
Name
|
Quantity
|
|
1.
|
Post Halela-e-Zard
|
300 g.
|
|
2.
|
Turbud Safaid
|
100 g.
|
|
3.
|
Rai
|
20 g.
|
|
4.
|
Tukhm Gandana
|
50 g.
|
|
5.
|
Gugal
|
150 g.
|
|
6.
|
Halela Siyah
|
150 g.
|
Marham Saeeda
Chob Neemwala
|
S.No
|
Name
|
Quantity
|
|
7.
|
Post Bakayin
|
10 g.
|
|
8.
|
Post Neem
|
10 g.
|
|
9.
|
Rasaut
Musaffa
|
10 g.
|
|
10.
|
Safaida
Kashghari
|
10 g.
|
|
11.
|
Gugal
|
10 g.
|
|
12.
|
Maghaz
Bakayin
|
10 g.
|
|
13.
|
Maghaz Neem
|
10 g.
|
|
14.
|
Kafoor
|
10 g.
|
|