| CTRI Number |
CTRI/2024/01/061859 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Fever with Unani medicine Cap Mubarak
|
|
Scientific Title of Study
|
A Single-blind, Randomized, Parallel group study to evaluate antipyretic effect of Unani Medicine formulation– Cap Mubarak compared to controlled drug Tab Paracetamol in patients with Humma (fever) |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| H/F/CM/P/RCT/CCRUM/22-23, version 01, 07/11/23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| 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 |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Deputy Director General |
| 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 |
naheedparveen802@gmail.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, Patna 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 Zikra Tahseen |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Research OPD Room Humma (Fever),Guzri, Patna City
Patna
BIHAR |
7904031411
zikra0210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cap Mubarak |
2 Cap of 500 mg to be taken orally twice daily with water for 3 days
|
| Comparator Agent |
Tab Paracetamol |
1 Tab of 500 mg to be taken orally twice daily with water for 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of either sex in the age group 18 to 65 years.
2. History of onset of fever within 24 hr.
3. Participants with oral temperature 100 F- 102 F presenting with any of the following symptoms:
Fever
Headache
Body ache
Joints pain
Shivering
Chills
Palpitation
Skin Flushing |
|
| ExclusionCriteria |
| Details |
1. Intake of any antipyretic drugs in the previous 8 hrs.
2. Participant having oral temperature of greater than 102 F.
3. Known high risk clinical conditions such as pneumonia, sepsis, dengue haemorrhagic fever,meningitis, hepatitis B, etc.
4. Known cases of Immuno-compromised clinical conditions such as HIV, cancer etc.
5. Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
6. Thrombocytopenia i.e. absolute platelet count below 1,00,000.
7. Known hypersensitivity to study drug or any of its ingredients.
8. Pregnant and Lactating females.
9. Diabetes Mellitus or any systemic disorder requiring prolonged treatment. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the study drug in the treatment of Humma (fever) will be assessed on the basis of reduction in the symptoms and change in temperature from baseline to end of the study and the achievement of defervescence, |
At baseline and on 3rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline and end of treatment i.e. 3rd day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/02/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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, Randomized, Single blind, Parallel Group Comparative Clinical trial in patients with Humma (Fever). Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients enrolled in the study will receive the medicine Cap Mubarak or Paracetamol as allocated by randomization method. The total duration of treatment will be 3 days and the follow-up for all clinical parameters will be conducted on baseline and at 3rd day.
Composition
of Cap Mubarak
|
S. No.
|
Ingredients
|
Botanical / English Name
|
Quantity
|
-
|
Maghz-e-Karanjawa
|
Caesalpinia
bonducella
|
2 parts
|
-
|
Zeera Safaid
|
Cuminum cyminum Linn.
|
-
|
Dar-e-Filfil
|
Piper longum Linn.
|
-
|
Barg-e-Babool
|
Acacia arabica Willd.
|
-
|
Kushta
Goadanti
|
Calx Gypsum
|
1 part
|
|