Home » Trials » SLCTR/2023/015
Safety assessment of a herbal capsule Asparagus falcatus L. in healthy adults: Phase 1 clinical trial of a herbal supplementation for non-alcoholic fatty liver disease
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SLCTR Registration Number
SLCTR/2023/015
Date of Registration
The date of last modification
Sep 13, 2023
Scientific Title of Trial
Safety assessment of a herbal capsule Asparagus falcatus L. in healthy adults: Phase 1 clinical trial of a herbal supplementation for non-alcoholic fatty liver disease
Public Title of Trial
Safety of an herbal capsule Asparagus falcatus L. in healthy human volunteers: A single-center, open-label, single arm phase 1 clinical trial.
Disease or Health Condition(s) Studied
Non-alcoholic fatty liver disease
Scientific Acronym
Public Acronym
Brief title
Safety assessment of a herbal capsule Asparagus
Universal Trial Number
U1111-1297-0053
Any other number(s) assigned to the trial and issuing authority
2022.P.065 (ERC, Faculty of Medicine, Ruhuna)
What is the research question being addressed?
Is daily ingestion of herbal capsule Asparagus falcatus L. for a period of three months safe in healthy human volunteers?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Phase 1
Intervention(s) planned
Study setting: Department of Biochemistry and Medicine, Faculty of Medicine, University of Ruhuna, Sri Lanka. Details of the interventional product: Oral capsules containing freeze-dried material of aqueous leaf extract of Asparagus falcatus L. (125, 250, 500mg) once daily for 3 months in monthly escalating doses as 125 mg- 1st month 250 mg- 2nd month 500 mg- 3rd month.
Inclusion criteria
• Healthy subjects as defined by medical history, anthropometry, examination -including systolic and diastolic blood pressure and baseline electrocardiography, hematological and biochemical investigations indicating normal liver and kidney function (BMI of < 23 kg/m2 will be considered as normal healthy weight based on WHO cut-off for Asian population, baseline investigations include full blood count, fasting plasma glucose (FPG), lipid profile, renal function test-serum creatinine, serum liver enzymes (ALT, AST, ALP, Gamma-glutamyl transferase (Gamma-GT), total bilirubin, and electrocardiogram (ECG).
• Males and females age 18–60 years
• Currently not on any medicines including nutritional supplements, herbal and/or Ayurvedic medicines.
Exclusion criteria
• Patients with any documented chronic illness, liver disease, and abnormal/ baseline values in the liver, renal function tests or blood counts
• Individuals with a family history of liver disease
• Female volunteers who are pregnant, lactating, or not willing to use an effective form of birth control during the period of study
• Alcohol users or any alcohol intake for the past six months
Primary outcome(s)
|
1.
Hematological parameters - parameters that are expected to be monitored: RBC, Hb, PCV, MCV, MCH, MCHC, PLT, and WBC. |
[ At baseline and monthly for a period of 3 months ] |
|
2.
Liver function -ALT, AST, ALP, gamma-GT, total bilirubin |
[ At baseline and monthly for a period of 3 months ] |
|
3.
Renal function -serum creatinine |
[ At baseline and monthly for a period of 3 months ] |
|
4.
Percentage of participants who experienced serious adverse events such as death, inpatient hospitalization, major change in hematological or biochemical parameters monitored (severe anemia, leucopenia or thrombocytopenia or biochemical evidence of acute kidney or liver injury), ECG evidence of myocardial injury, any disability or permanent damage, requires interventions to prevent permanent impairment or damage |
[ Monitored throughout the trial period ] |
Secondary outcome(s)
|
1.
Lipid profile (TC, TG, VLDL-C, HDL-C, LDL-C) |
[ At baseline and after a period of 3 months ] |
|
2.
Change in anthropometric variables (Height, weight, BMI) |
[ At baseline and monthly for a period of 3 months ] |
|
3.
Blood pressure and fasting plasma glucose concentration |
[ At baseline and monthly for a period of 3 months ] |
|
4.
ECG evidence of myocardial ischemia such as ST segment changes. |
[ At baseline and after a period of 3 months ] |
Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2023-10-01
Anticipated end date
2024-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Faculty Research Grant-2023, Faculty of Medicine, University of Ruhuna, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2022-08-23
Approval number
2022.P.065
Details of Ethics Review Committee
| Name: | Ethics Review Committee of Faculty of Medicine, University of Ruhuna, Sri Lanka |
| Institutional Address: | Faculty of Medicine, University of Ruhuna, PO Box 70, Galle, Sri Lanka |
| Telephone: | 0912234801 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Anoja Attanayake
Professor in Biochemistry
Department of Biochemistry, Faculty of Medicine, University of Ruhuna
+94912234801
+94714428121
+9491 2222314
anojaattanayake@med.ruh.ac.lk
Contact Person for Public Queries
Prof. Anoja Attanayake
Professor in Biochemistry
Department of Biochemistry, Faculty of Medicine, University of Ruhuna
+94912234801
+94714428121
+94912222314
anojaattanayake@med.ruh.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
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
