| CTRI Number |
CTRI/2019/02/017704 [Registered on: 18/02/2019] Trial Registered Prospectively |
| Last Modified On: |
18/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Fever with Unani medicine Sharbat Khaksi |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Sharbat
Khaksi in Humma (Fever) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| H/F/SK/CLNVAL/CCRUM /17-18, 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 |
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 |
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 |
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 |
drpradeepkumar@yahoo.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), Srinagar 4. Regional Research Institute of Unani Medicine (RRIUM), Chennai Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
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, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Arshad |
Central Research Institute of Unani Medicine (CRIUM) |
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
9415793159
marshadccrum64@gmail.com |
| Dr M Afsahul Kalam |
Regional Research Institute of Unani Medicine (RRIUM) |
Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR |
7051435488
afsahnium@gmail.com |
| Dr T Shahida Begum |
Regional Research Institute of Unani Medicine (RRIUM) |
1, West Madha Church, Royapuram
Chennai
TAMIL NADU |
9840648883
tshahidabegum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine, Lucknow |
Approved |
| Regional Research Institute of Unani Medicine, Chennai |
Approved |
| Regional Research Institute of Unani Medicine, Srinagar |
Submittted/Under Review |
|
|
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 |
| Comparator Agent |
nil |
nil |
| Intervention |
Sharbat Khaksi |
15 ml orally four time in one day with lukewarm water for one day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
· Patients of either sex in the age group of 18-65 years
· Patients having fever ≥100°F with or without any of the following symptoms
Sweating
Nausea
Malaise
Decreased appetite
General weakness
Headache
Myalgia
Loss of appetite
Larza (shivering)
Irritability |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded from the study:
1. Age below 18 and more than 65
2. Weak debilitating patients
3. Pregnancy and lactation
4. Known hypersensitivity to study drug or any of its ingredients |
|
|
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 Humma (Fever) |
one day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
at baseline and at the 2nd day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
18/02/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not 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 Humma (Fever) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline and of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one day. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of SharbatKhaksi
|
S. No.
|
Ingredients
|
Scientific Name
|
Quantity
|
|
1.
|
Badyan
|
Foeniculum vulgare Mill.
|
1.1 gm
|
|
2.
|
Barg Gaozuban
|
Borago
officinalis Linn.
|
0.66 gm
|
|
3.
|
Khaksi
|
Sisymbrium
irio Linn.
|
1.1 gm
|
|
4.
|
Unnab
|
Ziziphus
jujube Mill.
|
1.1 gm
|
|
5.
|
Shakar Safaid
|
Saccharum officinarum Linn. (Sugar)
|
16.5 gm
|
|
6.
|
Shahdeen
|
Honey
|
4.4 gm
|
|
7.
|
Sat Limun
|
Citric Acid
|
0.044 gm
|
|
8.
|
Natroon Punjabi
|
Sodium carbonate
|
0.022 gm
|
|
9.
|
Methyle Paraben
|
-
|
Q. S.
|
|
10.
|
Propyl Paraben
|
-
|
Q. S.
|
|
11.
|
Sodium Benzoate
|
-
|
Q. S.
|
|