| CTRI Number |
CTRI/2021/09/036474 [Registered on: 14/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Unani drug in the treatment of liver cirrhosis. |
|
Scientific Title of Study
|
“Clinical study for the evaluation of efficacy and safety of Unani formulation in the management of Cirrhosis of Liver†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NUZHAT PRAWEEN |
| Designation |
PG Scholar |
| Affiliation |
Jamia Hamdard University |
| Address |
Deptt. of Moalajat(Medicine), School of Unani Medical Education and Research, Jamia Hamdard University, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
989141927 |
| Fax |
|
| Email |
nuzhat1994dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Azhar Jabeen |
| Designation |
Asst. Professor |
| Affiliation |
Jamia Hamdard University |
| Address |
Deptt. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard University, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
09899315252 |
| Fax |
|
| Email |
ajabin@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Azhar Jabeen |
| Designation |
Asst. Professor |
| Affiliation |
Jamia Hamdard University |
| Address |
Deptt. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard University, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
09899315252 |
| Fax |
|
| Email |
jabeendr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptt. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard University, Hamdard Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Deptt of Moalajat School of Unani Medical Education and Research Jamia Hamdard University |
| Address |
Hamdard Nagar, New Delhi |
| 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 |
| NUZHAT PRAWEEN |
Majeedia Unani Hospital |
Deptt. of Moalajat, School of Unani Medical Education and Research, jamia Hamdard University, Hamdard Nagar, New Delhi 110062
South
DELHI |
9891419527
nXXXXXX994dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Unani Drug |
500mg capsule and 2 caps BD orally for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Radiological ( Elastography: Metavir score ≥ f4(i.e. more than 12kPa) evidence of liver cirrhosis
Child-turcotte-Pugh Score A and B
|
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers
Mentally retarded patients
Patients who failed to give informed consent
Patient with Hepatic Encephalopathy
Patients with comorbid heart and kidney disease
History of active bleeding
Severe bacterial infection
History of malignancy
Patient whose CHILD PUGH score lies in category C
Uncontrolled Diabetes Mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MELD Score
APRI Score
PT/INR,
Hb level
A/G Ratio
Child Pugh Score |
0 Baseline, 15th day, 30th day, 60th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of Life
(SF12 Questionnaire) |
0 Baseline, 15th day, 30th day, 60th day, 90th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/09/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study entitled “Clinical study for the evaluation of efficacy and safety of Unani formulation in the management of Cirrhosis of Liver†is open label, single arm study will be carried out in department of Moalajat, Majeedia Unani Hospital, Jamia Hamdard, New Delhi. Diagnosed patients of cirrhosis of liver, who fit into the inclusion criteria, will be enrolled for the study. Test drugs which are selected for the study are safe and effective in liver diseases are mentioned in Unani literature. The test drugs will be prepared in the PG lab of department of Moalajat. Standardization and extraction of test drugs will be conducted in the department of Ilmul Advia, School of Unani Medical Education and Research, Jamia Hamdard. A written consent sheet will be provided to the patient in a language known to him/her before enrolment. Duration of the therapy will be three months with sample size of 30 patients and the follow up will be at baseline,15th ,30th,60th and 90th day. The Mizaj(temperament) of the patients will be assessed before treatment. The parameters for evaluation of efficacy and safety will be clinical sign and symptoms, MELD score, Child Pugh score, APRI score, biochemical parameters (CBC with ESR, LFT, KFT, B. Sugar, S. Electrolytes, S.GGT, HbA1C, HBsAg, AHCV, PT/INR and radiological parameters (USG and Fibroscan). The investigations will be done before the treatment, on 30th day and after completion of the treatment. At the end of the study the data thus generated will be statistically analyzed. |