| CTRI Number |
CTRI/2023/01/048981 [Registered on: 13/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of decrease in desire to eat with Unani medicine Safoof Hazim Kalan |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Safoof Hazim Kalan in Zof e lshteha (Anorexia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZI/A/SHK/CLNVAL/CCRUM/20-21, version 01 dated 18/11/2022 |
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 |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| 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 |
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 |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| 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 |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashid ul Islam |
Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Research OPD Room Zofe lshteha (Anorexia), Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
9897975161
waytorashid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R630||Anorexia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Safoof Hazim Kalan
|
2-5gm powder twice daily orally To be taken with water after meals for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any sex in the age group 18-65 years.
2. Patients having Zof e lshteha(Anorexia) with SNAQ score≤14
|
|
| 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 sign and symptoms of Zof e lshteha (Anorexia) on the basis of improvement in the appetite for which the Simplified Nutritional Appetite Questionnaire (SNAQ) |
On baseline, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and end of the treatment i.e. 14th day |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
17/01/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single centric open trial in patients with Zof e lshteha (Anorexia). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on 7th and 14th day. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Safoof Hazim Kalan
|
S.No.
|
Ingredients
|
Quantity
|
|
1.
|
Post Halela Zard
|
20g
|
|
2.
|
Post Balela
|
20g
|
|
3.
|
Aamla
|
20g
|
|
4.
|
Badiyan
|
20g
|
|
5.
|
Nankhwah
|
20g
|
|
6.
|
Zeera Safaid
|
20g
|
|
7.
|
Namak-E-Sang
|
20g
|
|
8.
|
Namak Siya
|
20g
|
|
9.
|
Namak Hindi
|
20g
|
|
10.
|
Jawakhar
|
20g
|
|
11.
|
Tankar Biryan
|
10g
|
|
12.
|
Naushadar
|
10g
|
|
13.
|
Filfil Siyah
|
10g
|
|
14.
|
Dana Heel Khurd
|
10g
|
|
15.
|
Zanjabeel
|
10g
|
|
16.
|
Filfil Daraz
|
10g
|
|