| CTRI Number |
CTRI/2025/02/080481 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Unani Formulation ( Jawarish Falafali) in Chronic Fatigue Syndrome |
|
Scientific Title of Study
|
Efficacy of Jawarish Falafali in Chronic Fatigue Syndrome : A Randomized Double-blind Placebo-Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishrat Mohammed Israr |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
7208764460 |
| Fax |
|
| Email |
mkhansana22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faseeha Eram |
| Designation |
Lecturer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8791701225 |
| Fax |
|
| Email |
faseehaeram9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Faseeha Eram |
| Designation |
Lecturer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8791701225 |
| Fax |
|
| Email |
faseehaearm9@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru- 560091, INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru- 560091 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ishrat Mohammed Israr |
National Institute of Unani Medicine |
Department of Moalajat OPD No 1 and 2 NIUM Hospital Kottigepalya Magadi Main Road Bengaluru 560091
Bangalore
KARNATAKA |
7208764460
mkhansana22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R538||Other malaise and fatigue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jawarish Falafali |
6 grams twice a day orally with water after meals for 30 days |
| Comparator Agent |
Placebo |
wheat flour in form of jawarish as a placebo
6 grams twice a day orally with water after meals for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of CFS/ME according to the Fukuda criteria.
Age ranges from 18 to 60 years.
All genders.
Voluntary participation and signing the informed consent. |
|
| ExclusionCriteria |
| Details |
known cases of anemia, thyroid disorder, vitamin B12, folate deficiency
Newly diagnosed and known cases of diabetes mellitus
systemic illness like rheumatoid arthritis, cardiovascular disease, respiratory illness, coeliac disease, IBD, epilepsy, carcinoma, etc
known cases of severe depression or cases diagnosed with depression according to PHQ 9 questionnaire
chronic alcoholism
drug abuse
subject with uncontrolled hypertension more than 140/90 mmhg in patient already on antihypertensive medication
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Chalder Fatigue Scale |
0th 10th 20th and 30th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Fibro Fatigue Scale
Improvement in SF-36 Quality of life Scale
Improvement in Subjective Parameters |
0th 10th 20th and 30th days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
04/04/2025 |
| 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="1"
Months="6"
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
|
Purpose: To Evaluate the Efficacy of Jawarish Falafali in Chronic Fatigue Syndrome Design: A randomized double-blind placebo controlled clinical trial Intervention: A test group will be given Jawarish Falafali 12gm in two divided doses, and a Placebo (Wheat flour) will be given in the same as of test group. Main Outcome Measures: Primary outcome: Improvement in Chalder Fatigue Syndrome Secondary outcome: Improvement in FibroFatigue Scale, Improvement in SF-36 Quality of life Scale, Improvement in Subjective parameters. |