| CTRI Number |
CTRI/2025/01/078881 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Unani Formulation(Qurs e Afsanteen) in Non-Alcoholic Fatty liver disease |
|
Scientific Title of Study
|
Efficacy of Qurs e Afsanteen in Non-Alcoholic grade
1 and 2 Fatty Liver Disease: A randomized 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 |
Mohammed Atiq Raza |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept.Tahaffuzi wa samaji tib, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India
Boys hostel, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560091
India |
| Phone |
9972839343 |
| Fax |
|
| Email |
razamohammedatiq@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zarnigar |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept.Tahaffuzi wa samaji tib, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560091
India |
| Phone |
7483244027 |
| Fax |
|
| Email |
kzarnigar15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Atiq Raza |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept.Tahaffuzi wa samaji tib, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India
Boys hostel, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560091
India |
| Phone |
9972839343 |
| Fax |
|
| Email |
razamohammedatiq@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Tahaffuzi wa sami tib, OPD(room no 3) and IPD of National Institute of Unani medicine hospital, Bangalore, Karnataka, India-560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Dept of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India |
| 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 Mohammed Atiq Raza |
National Institute of Unani Medicine |
OPD no 3 Dept of Tahaffuzi wa Samaji Tib, OPD block, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, India- 560091
Bangalore
KARNATAKA |
9972839343
razamohammedatiq@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: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qurs e Afsanteen |
Qurs(tablet) made of afsanteen, tukhm e karafs, asaroon and maghz e badam binded with water made of size 1gm each ,will be given 5gms twice daily with water for 60days |
| Comparator Agent |
Roasted Wheat flour |
Wheat flour is roasted and made in the form of tablet of 1 gm each , given 5gm twice daily for 60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Non-Alcoholic Fatty liver grade 1(Mild) and grade 2(moderate) based on
ultrasonography
2) Patients of both genders
3) Age group of 20 TO 60 years
4) BMI less than 39.9
5) If Alcoholic (Male less than 30gms per day And Female less than 20gms per day) |
|
| ExclusionCriteria |
| Details |
1)Pregnancy and lactation
2)Fatty liver of grade 3rd (severe) and above.
3)Patients with serious co morbid condition BP 140/90 mmHg and liver failure and renal failure and Hepatic cirrhosis and Cancer and other endocrine illnesses and other
types of fatty liver disease caused by Alcohol viral or autoimmune hepatitis and Wilson’s Disease and Chronic disease like CHS Decomposed lung diseases and Carrier of HIV
4)BMI more than 39.9
5)Patients on hypolipidemic drugs
6)Recurrent drug use
7)Excessive Alcohol intake (Average alcohol intake Male more than 30gms per day and Females more than 20gms per day)
8)History of infection surgery trauma hospitalization in past 30days
9)Chronic degenerative disease of non-hepatic region
10)Non-compliance with the treatment
11) Failure to follow up or refusal to continue the study protocol
12) History of Drug use like (Amiodarone Methotrexate Corticosteroids Estrogen warfare Anti-convulsions drugs Anti-psychotic drugs Chemotherapy drugs and any medication for liver in past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Changes in grading of fatty liver (USG)
2)Changes in SGOT and SGPT levels
3)Changes in lipid profile |
at baseline (0th day), and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Changes in waist circumference 2) Changes in BMI |
at baseline, 15th day, 30th day, 45th day and on 60th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/02/2025 |
| 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="0"
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
|
Nonalcoholic Fatty Liver Disease (NAFLD) is known to be the most prevalent hepatic
disorder that characterized by excessive hepatic fat accumulation, in absence of
remarkable alcohol consumption. Frequently linked to other metabolic diseases such
as hyperlipidemia, cardiovascular diseases, hepatocellular carcinoma, type 2 Diabetes
mellitus and obesity. According to studies, NAFLD and its link to obesity will considerably increase liver
related morbidity and mortality by 2030. The prevalence of NAFLD varies among
different populations, with the Middle East having the highest rates (32% of the
population is thought to be affected), followed by the United States and South America
(30%). The estimated prevalence for other regions, including Asia, Europe, and Africa,
ranges from 13% to 27%. Nonalcoholic fatty liver disease is considered to be a hepatic manifestation of
metabolic syndrome. NAFLD encompasses a spectrum of liver pathology with
different clinical prognoses. It is characterized by the simple accumulation of
triglycerides within hepatocytes (hepatic steatosis). The most clinically ominous
extreme are cirrhosis and primary liver cancer. Current trends of management of
Nonalcoholic fatty liver disease include lifestyle modification by Diet and exercise and
Thiazolidinediones, biguanides (to increase insulin sensitivity), Statin (to prevent
cholesterol synthesis), Antioxidants (oxidative stress is thought to be an important
factor for the progression of NAFLD). Biguanides are increasingly being abandoned
because of their hepatotoxicity and Thiazolidinediones causes Edema and Congestive
Heart Failure, Weight Gain, Fractures, Bladder Cancer, Hepatotoxicity, Diabetic
Macular Edema, Increased Ovulation and Teratogenic Effects. Statin causes digestive
system problems, muscle pain, sleep problems, low blood platelet count, memory
problems, hair loss, hepatitis, pancreatitis, sexual problems. In view of Unani medicine balghami and saudawi mizaj persons are slow metabolizers
due to deficient digestive power. Excessive use of cold and moist food, inadequate
quantity and improper timing of food intake produces excess of cold and moist humors
after metabolism and also increases coldness and humidity in liver and stomach. that
results in weakness of quwwate jaziba and quwwate hadima in liver and weakens
digestion. In this condition blood formed is rich in balgham. Coldness produces
Ghaleez and Luzuj Akhlat, further increase in coldness congelate serous humor that is
known as Shaham , thick and viscid matter also accumulates in liver and causes
inflammation in liver and obstruction in vessels and canals within the liver where
chyme metabolized. Grade 1 and 2 of NAFLD in Unani medicine may correlate with Sue mizaj barid ratab
maddi in liver (abnormal substantial cold and moist temperament) and grade 3 and
higher corelate with Sue mizaj barid yabis maddi in liver that causes obstruction in
liver.
Unani physicians, advised the use of musakhin, mujaffif , mulattif , muqawwie maida
and muqawwie jigger advia to correct the mizaj (temperament) of liver and to restore
the quwwate jaziba and hadima of liver and to liquify the accumulated thick and viscid
matter in the liver for example qurse rewand, qurse afsanteen, qurse ghafis, dawa al
kurkum, qurse luk, kasoos, usare ghafis, Dar chini, qarnfal, rewand chini, asaroon,
aneesoon, tukhme karafs etc.
Out of these Qurse afsanteen was chosen because of several reasons. First, its
efficacious use has been documented in Unani literature. Second, hypolipidemic,
hepatoprotective and antioxidant activities has been verified in the ingredients of qurse
afsanteen in animal studies. |