| CTRI Number |
CTRI/2015/02/005528 [Registered on: 11/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of Unani formulation in the treatment of Dyspepsia |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulations Jawarish e Kamooni and Arq e Badiyan in Sū’ al-Hadm (Dyspepsia)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SH/D/JKAB CLNVAL/CCRUM 13-14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF S SHAKIR JAMIL |
| Designation |
DIRECTOR GENERAL |
| 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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K M SIDDIQUI |
| Designation |
DEPUTY 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
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum507@gmail.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 |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: 1.Central Research Institute of Unani Medicine (CRIUM), Lucknow 2.Regional Research Institute of Unani Medicine (RRIUM), Patna 3.Regional Research Institute of Unani Medicine (RRIUM), Kolkata 4.Clinical Research Unit (CRU), Meerut 5.Clinical Research Unit (CRU), Kurnool
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 |
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 = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ZIAUL HAQUE SIDDIQUI |
CENTRAL RESEARCH INSTITUTE, LUCKNOW |
C 39 TEHRI PULIA, PO SECTOR C JANKIPURAM
Lucknow
UTTAR PRADESH |
05222732088
crium_lko@yahoo.co.in |
| DR JAWADUL HAQ |
Clinical Research Unit (CRU), Kurnool |
DR ABDUL HAQ UNANI MEDICAL COLLEGE, 40/23 PARK ROAD
Kurnool
ANDHRA PRADESH |
09502443555
cru.kurnool@gmail.com |
| DR MOHD TARIQ KHAN |
Clinical Research Unit (CRU), Meerut |
Gulzar-e- Ibrahim, Gali No. 2, Tanki Wali Gali, Bhomiya Ka Pul, lesari Road
Meerut
UTTAR PRADESH |
9012843253
doctormtk@gmail.com |
| DR MOHAMMAD NAWAB |
Regional Research Institute of Unani Medicine (RRIUM), Kolkata |
79, CHITRANJAN AVENUE, KOLKATA
Kolkata
WEST BENGAL |
03322372107
03322372107
drnawab20022000@gmail.com |
| DR MOHAMMAD ISHTIYAQ ALAM |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Manas Path opp. Patna City Hospital
Patna
BIHAR |
06122631106
rriumpatna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Clinical Research Unit (CRU), Kurnool |
Approved |
| Clinical Research Unit (CRU), Meerut |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Kolkata |
Approved |
| CENTRAL RESEARCH INSTITUTE, LUCKNOW |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, Sū’ al-Hadm (Dyspepsia), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Jawarish e Kamooni
2.Arq e Badiyan |
1.Jawarish e Kamooni ,Orally,5 gm Twice daily, with water after meals
2.Arq e Badiyan Orally,60 Twice daily with water
after meals
Duration of treatment 2 weeks
|
| Comparator Agent |
nil |
na |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-55 years.
2. Patients having abdominal discomfort with any of the following symptoms of Sū’ al-Hadm (Dyspepsia) due to Sū’-i-MizÄj BÄrid:
• Abdominal pain
• Heartburn
• Acid Regurgitation
• Eructation
• Nausea and Vomiting
• Abdominal Distention
|
|
| ExclusionCriteria |
| Details |
• Dysphagia
• Inflammatory Bowel Disease e.g. Ulcerative colitis, Crohn’s Disease
• Palpable abdominal mass
• History of Zollinger ellison syndrome
• History of sudden weight loss
• History of long-term medication
• Known cases of cancer, anaemia/ haematemesis/ melaena
• Known cases of severe hepatic, renal or cardiac ailments
• Diabetes Mellitus
• H/o addiction (tobacco chewing, smoking, alcohol, drugs)
• Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Sū’ al-Hadm (Dyspepsia) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
2 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)
|
01/02/2014 |
| 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 Sū’ al-Hadm (Dyspepsia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every week. 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 end of study.
Composition of Jawarish e Kamooni
|
S. No.
|
Unani Name
|
Scientific Name
|
Weight
|
|
1.
|
Zeera Siyah Mudabbar
|
Cuminum
cyminum
|
350 g
|
|
2.
|
Barg-e-Sudab
|
Ruta graveolens
|
350 g
|
|
3.
|
Filfil Siyah
|
Piper nigrum
|
350 g
|
|
4.
|
Zanjabeel
|
Zingiber
officinale
|
350 g
|
|
5.
|
Boora-e-Armani
|
Borax
|
100 g
|
|
6.
|
A‘sal or Qand Safaid
|
Honey or Sugar
|
5 kg
|
Composition
of Arq-e- Badiyan
|
S.
No.
|
Unani
Name
|
Scientific
Name
|
Weight
|
|
1.
|
Badiyan
|
Foeniculum vulgare
|
01
Part
|
|
2.
|
Aab
|
Oxidane (Water)
|
20 Parts
|
|