| CTRI Number |
CTRI/2018/12/016577 [Registered on: 10/12/2018] 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-Hilteet in Zu‘f al-IshtihÄ’ (Anorexia) |
|
Scientific Title of Study
|
Clinical Validation of a Unani Pharmacopoeial Formulation - Habbe-Hilteet in Zuf al-lshtiha (Anorexia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZI/A/HH CLNVAL/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 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
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 |
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
|
| InfrastructuralSupport:1.Regional Research Institute of Unani Medicine, New Delhi 2.Regional Research Institute of Unani Medicine Patna, 3. Regional Research Institute of Unani Medicine Chennai 4.Clinical Research Unit Bangalore Monetary Support : Central Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Najeebul Hassan |
Clinical Research Unit (CRU) |
NIUM, Kotegaepalya, Magadi Road
Bangalore
KARNATAKA |
9886704083
crubangalore2000@yahoo.com |
| Dr Noman Anwar |
Regional Research Institute of Unani Medicine |
1, WEST MADHA CHURCH ROAD, ROYAPURUM
Chennai
TAMIL NADU |
9990306137
nanomananwar@gmail.com |
| Dr Rajesh |
Regional Research Institute of Unani Medicine |
Guzri, Patna City
Patna
BIHAR |
88052188543
drrajesh.baba@gmail.com |
| Dr S A H Zaidi |
Regional Research Institute of Unani Medicine |
D 11 Abul Fazal Enclave, Jamia Nagar
South
DELHI |
9312039212
rriumdelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Chennai |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
| Clinical Research Unit (CRU), Bangalore |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, New Delhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R630||Anorexia, Zu‘f al-IshtihÄ’ (Anorexia), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Hilteet ( 500 md Tablet) |
One tablet twice daily orally 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 19-65 years
2. Patients having Zu‘f al-IshtihÄ’ (Anorexia)
|
|
| ExclusionCriteria |
| Details |
1. Patients having Anorexia nervosa
2. Patients having any systemic disease, chronic debilitating disease, T.B., Diabetes Mellitus etc.
3. Known cases of Hepatic, Renal or Cardiac Ailments
4. History of hypersensitivity to study drug or any of its ingredients.
5. History of addiction (Alcohol, Drugs)
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 Zu‘f al-IshtihÄ’ (Anorexia) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and end of treatment ie 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)
|
02/03/2016 |
| 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
|
None Yet |
|
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 Zu‘f al-IshtihÄ’ (Anorexia) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline, 7th & 14th day of treatment. 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 therapy.
|
S. No.
|
Ingredients
|
Botanical / English Name
|
Quantity
|
|
1.
|
Hilteet
|
Ferula foetida
|
1 Part
|
|
2.
|
Zanjabeel
|
Zingiber
officianale
|
1 Part
|
|
3.
|
Tankar Biryan
|
Sodium Borate/ Borax (Roasted)
|
1 Part
|
|
4.
|
Namak-e-Sang
|
Rock salt
|
1 Part
|
|