Home » Trials » SLCTR/2022/030
Determination of the effects of herbal tea made of Osbeckia octandra on hepatic steatosis in metabolic dysfunction associated fatty liver disease.
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SLCTR Registration Number
SLCTR/2022/030
Date of Registration
The date of last modification
Dec 28, 2022
Scientific Title of Trial
Determination of the effects of herbal tea made of Osbeckia octandra on hepatic steatosis in metabolic dysfunction associated fatty liver disease.
Public Title of Trial
Comparing the effects of herbal tea made of Osbeckia octandra on hepatic steatosis and hepatic fibrosis in patients with Metabolic associated fatty liver disease (MAFLD compared to standard therapy: a randomized control trial.
Disease or Health Condition(s) Studied
metabolic dysfunction associated fatty liver disease
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U111-1269-0819
Any other number(s) assigned to the trial and issuing authority
38/22
What is the research question being addressed?
Does herbal tea made of O. octandra significantly improve hepatic steatosis and hepatic fibrosis in patients with Metabolic associated fatty liver disease (MAFLD)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Single
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Setting: Department of Gastroenterology, Colombo North Teaching Hospital, Ragama
Randomization: Simple randomization
Intervention: Product: The airtight dry ingredient sachet packet will be prepared by including O. octandra (Heen Bowitiya) plant powder (6g). The O. octandra powder will be purchased from an authenticated seller.
The herbal tea will be prepared by dipping the contents of the packet in 1 cup (250ml) of boiling water for 10 minutes and then it will be strained by a tea-strainer.
Frequency: 250ml 3 times a week.
Randomization: Simple randomization
Control: Patients with MAFLD under standard therapy.
Inclusion criteria
• All patients with ultrasonically proven fatty liver disease, who are attending the Liver Clinic of Gastroenterology & Hepatology Department at CNTH-Ragama and NHSL Colombo
• MAFLD patients diagnosed based on following criteria:
o histological (biopsy), imaging or blood biomarker evidence of hepatic steatosis
o with one of the following three criteria,
o Overweight/ obesity (BMI ?23 kg/m2 in Asians)
o Type 2 diabetes mellitus (FBS ?7.0mmol/L (126mg/dL), HbA1C ? 6.5%, OGTT ? 200 mg/dL
o Evidence of metabolic dysregulation (at least 2 of the following criteria need to be met)
o Waist circumference ?90/80 cm in Asian men and women
o Blood pressure ?130/85 mmHg or specific drug treatment
o Plasma triglycerides ?150 mg/dl (?1.70 mmol/L) or specific drug treatment
o Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment
o Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9 mmol/L], or 2-hour post-load glucose levels 140 to 199 mg/dl [7.8 to 11.0 mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])
o Homeostasis model assessment of insulin resistance score ?2.5
o Plasma high-sensitivity C-reactive protein level >2 mg/L
• Age 18–60 years (male and female)
Exclusion criteria
• History of alcohol consumption of ?14 units/week for women and ?21 units/week for men. • Patients who have been diagnosed with other known causes of liver disease (HBV and HCV and autoimmune hepatitis) • Presence of clinical, radiological, biochemical and or endoscopic evidence of cirrhosis • Patients who are on medications for other chronic disease including hypertension, diabetes mellitus and hyperlipidaemia. • Any diagnosed malignancy • Breast feeding, pregnant, and/or planning for pregnancy in the within one year • The patients who are already taking or recently used (within 6 months) herbal preparations or Ayurvedic treatment for any condition. • People who are allergic to herbal preparations.
Primary outcome(s)
|
1.
Liver Fibrosis by Fibroscan. Liver stiffness measurement (LSM) using non-invasive transient elastography (TE) is used to assess the hepatic fibrosis. |
[ Baseline and four months after intervention ] |
|
2.
Liver Steatosis by Fibroscan Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in theur liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[] |
|
3.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
4.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
5.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
6.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
7.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
8.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
9.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
10.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
11.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
12.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
13.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
14.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
15.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
|
16.
Liver Steatosis by Fibroscan. Controlled Attenuation Parameter (CAP) score is a measurement of fatty change in the liver to provide a steatosis grade. The CAP score is measured in decibels per meter (dB/m). |
[ Baseline and four months after intervention ] |
Secondary outcome(s)
|
1.
Change in mean of following parameters: AST, ALT, GGT, ALP, total protein, albumin, globulin, total bilirubin and direct bilirubin, lipid profile values, TSH, T3 T4, HbA1c, Fasting blood glucose level, high-sensitivity CRP |
[ Baseline and four months after intervention ] |
Target number/sample size
120 (60 per arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2023-02-01
Anticipated end date
2024-12-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Research Grant from the University of Jayewardenepura
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2022-09-29
Approval number
38/22
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical sciences, University of Sri Jajewardenepura |
| Institutional Address: | Ethics Review Committee, Faculty of Medical sciences, University of Sri Jajewardenepura, Gangodawila, Nugegoda. |
| Telephone: | 0112758588 |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dilhara Karunaratna
Senior lecturer
Department of Basic sciences,
Faculty of Allied Health Sciences
General Sir John Kotelawala Defense University
Ratmalana.
+94783978405
dilmck@yahoo.com
Contact Person for Public Queries
Prof Sagarika Ekanayake
Senior Professor
Department of Biochemistry Faculty of Medicine University of Sri Jayawardenapura Sri Lanka.
+94716875891
sagarikae@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results of the trial after deidentification will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be made available beginning 3 months and ending 5 years following article publication. Proposals should be directed to dilmck@yahoo.com. To gain access, data requestors will need to sign a data access agreement.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
