| CTRI Number |
CTRI/2013/12/004262 [Registered on: 31/12/2013] 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 formulations in the treatment of Dysentery
|
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Tiryaq-e-Pachish in Zaheer (Dysentery)
|
| 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 |
| 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
South
DELHI
110058
India |
| Phone |
011-28521981 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Hannan |
| Designation |
JOINT DIRECTOR |
| 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
DELHI
110058
India |
| Phone |
011-28521981 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Hannan |
| Designation |
JOINT DIRECTOR |
| 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
DELHI
110058
India |
| Phone |
011-28521981 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1 Regional Research Institute of Unani Medicine(RRIUM), New Delhi
2. Clinical Research Unit, Meerut
Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Monetary Support 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MOHD TARIQ KHAN |
CLINICAL RESEARCH UNIT |
Gulzar-e- Ibrahim, Gali No. 2, Tanki Wali Gali, Bhomiya Ka Pul, lesari Road, Meerut
Meerut
UTTAR PRADESH |
09012843253
doctormtk@gmail.com |
| DR SEEMA REHAN |
Regional Research Institute of Unani Medicine, New Delhi |
D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25
South
DELHI |
011-26952759
011-26952759
rriumdelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| CRU, MEERUT INSTITUTIONAL ETHICS COMMITTEE, DR MOHD TARIQ KHAN, PRINCIPAL INVESTIGATOR, MEERUT |
Approved |
| RRIUM NEW DELHI INSTITUTIONAL ETHICS COMMITTEE, NEW DELHI, DR SEEMA REHAN, PRINCIPAL INVESTIGATOR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A060||Acute amebic dysentery, DYSENTRY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Tiryaaq e Pechish |
5gm BD orally for one week
Duration of Therapy is one week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Age-20-60
• Increased frequency of motion
• Tenesmus
• Sense of incomplete evacuation
• Frequent constipation followed by diarrhoea
• Loose stools with or without mucous
• Associated symptoms like Nausea /Flatulence /Vomiting
|
|
| ExclusionCriteria |
| Details |
1 Patients with severe loose motion more than 8 in a day
2 Patients with blood in stool
3 Cholera/Ulcerative colitis
4 High grade fever (more than 101 ºC)
5 Patient having illnesses requiring long term treatment especially DM, CRF,HT
|
|
|
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 |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
1 WEEK |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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 Zaheer(Dysentry). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The clinical follow-up will be carried out every alternate day.This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 01 week. Laboratory parameters for safety assessment will be conducted at baseline and end of study. |