Slctr

Phase 1 clinical trial to determine safety of a herbal formulation LLC in healthy human volunteers.

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SLCTR Registration Number

SLCTR/2021/030

Date of Registration

09 Nov 2021

The date of last modification

Nov 09, 2022

Trial Status

Application Summary

Scientific Title of Trial

Phase 1 clinical trial to determine safety of a herbal formulation LLC in healthy human volunteers.

Public Title of Trial

Safety and acceptance of a herbal formulation Link LivecareTM (LLC) proposed to be used for fatty liver disease in healthy human volunteers-A single center open label Phase 1 clinical trial.

Disease or Health Condition(s) Studied

Liver disease

Scientific Acronym

None

Public Acronym

None

Brief title

Safety and acceptance of a herbal formulation LLC in healthy human volunteers

Universal Trial Number

U1111-1269-9634

Any other number(s) assigned to the trial and issuing authority

EC-21-048, UOC

Trial Details

What is the research question being addressed?

Is Link LivecareTM herbal tablet, formulated using Ayurvedic Medicine recipes used for treating liver diseases have adequate safety and acceptance by healthy volunteers?

Type of study

Interventional

Study design

Allocation

Single arm study

Masking

Masking not used

Control

Uncontrolled

Assignment

Single

Purpose

Other

Study Phase

Phase 1

Intervention(s) planned

This study will be conducted at the Faculty of Medicine, University of Colombo. Healthy volunteers will be recruited by an open advertisement. Healthy volunteers who fulfill the inclusion criteria will be recruited to the study. LLC is a polyherbal formulation containing the medicinal plants Andrographis paniculata, Eclipta alba, Phyllanthus amarus, Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Tinospora cordifolia, Curcuma longa, Glycyrrhiza glabra, Boerhavia diffusa, Osbeckia octandra, Tephrosia purpurea, Piper longum and Vernonia cinerea. It is developed and manufactured by the Link Natural Products (Pvt) Ltd. The dose of 900 mg, maximum recommended starting dose (MRSD) will be delivered using two tablets of the investigated product (450 mg extracts per tablet) as a single daily dose. This trial will be conducted over a 4-month period. The product will be administered only for a three-month period. Participants will be monitored for another month after the last dose for safety parameters and any withdrawal symptoms..

Inclusion criteria

The volunteers provides written informed consent before starting the study.
Volunteers who are in the age group 18 years to 60 years, healthy as defined by history, examination and systolic and diastolic blood pressure, and those who have normal baseline investigations, those who have normal liver function (serum bilirubin, AST, ALT, ALP, GGT, Serum albumin, FBS, coagulation tests (PT/INR)), renal function (urine full report, serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan will be recruited to the study.
Both male and unmarried female volunteers will be recruited to the study. Any female volunteer planning to get married during the 4 months after recruitment to the study will excluded from the study.

Exclusion criteria

Volunteers with a history of chronic illness such as diabetes mellitus, hypertension, cardiovascular diseases, chronic liver and kidney disease, and any other disease that warrants long term medication (e.g., autoimmune disease).
Volunteers who have abnormal baseline investigations by history, examination, systolic and diastolic blood pressure, and those who have abnormal liver function (serum bilirubin, AST, ALT, ALP, GGT, serum albumin, FBS, coagulation tests (PT/INR)), renal function (Urine full report, Serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan would be excluded from the trial.
Volunteers on any medicines, including nutritional, Ayurveda/ herbal supplements.
Married women volunteers and any women planning to get married during the 4 months after recruitment to the study.
Allergies or allergic reactions to any of the ingredients of LLC.

Primary outcome(s)

1. Vital signs (Weight/kg, height/m, respiratory rate (breaths/min), heart rate (breaths/min), blood pressure (mm/Hg).	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]
2. Hematological parameters (FBC & ESR)	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]
3. Liver profile (AST, ALT, ALP, GGT, Serum albumin, total bilirubin, total protein, coagulation tests (PT/INR), FBS and HbA1c).	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]
4. Renal function (UFR, Serum creatinine, GFR, Na+, K+, Ionized Ca2+, Mg2+ and Uric acid)	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]
5. Cardiovascular system (CVS)(ECG, Total cholesterol, Triglyceride, HDL, LDL, VLDL, Total cholesterol /HDL ratio and LDL/HDL ratio)	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]
6. Physical examination (Eyes, ears, nose, throat, general appearance, skin, respiratory system, CVS, CNS and abdomen)	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]

Secondary outcome(s)

1. Percentage of participants who experienced adverse events/adverse reactions. ADR will be assessed by a medical investigator.	[ Throughout the study period ]
2. Acceptability of the product will be evaluated using the validated medication acceptability questionnaire (MAQ).	[ At baseline, 1st month, 2nd month, 3rd month and 4th month ]

Target number/sample size

Countries of recruitment

Sri Lanka

Anticipated start date

2022-01-01

Anticipated end date

2022-06-01

Date of first enrollment

2022-02-28

Date of study completion

Recruitment status

Complete: follow up continuing

Funding source

Link Natural Products (PVT) Ltd

Regulatory approvals

Not applicable

State of Ethics Review Approval

Status

Approved

Date of Approval

2021-09-17

Approval number

EC-21-048

Details of Ethics Review Committee

Name:	Ethics Review Committee of the Faculty of Medicine
Institutional Address:	Faculty of Medicine. University of Colombo. No.25,Kynsey Road, Colombo 08. Sri Lanka.
Telephone:	+94 112 695 300 ext: 240
Email:	ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Prof. Colvin Goonaratne
Consultant Clinical Trials
Research & Development center, Link Natural Products (Pvt) Limited, Malinda, Kapugoda
0115606060
0773761205
0112409293
info@linknaturalproducts.com

Contact Person for Public Queries

Prof. Jennifer Perera
Consultant
Research & Development Center, Link Natural Products (Pvt) Limited, Malinda, Kapugoda
0115606060
0776096002
0112409293
jennifer_perera55@yahoo.com

Primary study sponsor/organization

Link Natural Products (Pvt) Limited

Link Natural Products (Pvt) Limited, Malinda, Kapugoda
0115606060
0112409293
info@linknaturalproduct.com
https://linknaturalproducts.com/

Secondary study sponsor (If any)

Trial Completion details

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 being reported, after de-identification (text, tables, figures and appendices) will be shared. The study protocol will be shared. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared initially with investigator team and drug safety monitoring board (DSMB) approved by ERC and later anyone who wishes to access the data after publication. Data will be shared to achieve the aims of the approved proposal. Proposals should be directed to info@linknaturalproducts.com email address. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication.

Study protocol available

Yes

Protocol version and date

Version number:2.1, 30th August 2021( ERC approved study protocol

Protocol URL

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results