| CTRI Number |
CTRI/2016/07/007123 [Registered on: 29/07/2016] Trial Registered Prospectively |
| Last Modified On: |
17/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Study of a Novel Composition of Boswellia serrata in Comparison With a Commercial Product in Improving Knee Joint Health in Non-Osteoarthritic Subjects. |
|
Scientific Title of Study
|
A Randomized Double-Blind Placebo Controlled Clinical Study for Comparative Evaluation of Efficacy and Tolerability of a Novel Composition and a Commercial Extract of Boswellia serrata in Improving Knee Joint Health of Non-Osteoarthritic Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/JH/LI13019F1/16, Version 02 dated 06-May-2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Venkateshwarlu |
| Designation |
Consultant- Ayurvedic & Herbal Clinical Trials |
| Affiliation |
Anasuya Ayurveda Clinic |
| Address |
50 feet Main Road, Hanumanthanagar
Bangalore
KARNATAKA
560050
India |
| Phone |
09945232107 |
| Fax |
|
| Email |
drvenkatesh64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A V Krishna Raju |
| Designation |
Head, Project Management |
| Affiliation |
Laila Nutraceuticals |
| Address |
Survey No 181/2, 181/3, 181/4B,
JRD TATA Industrial Estate,
Kanuru, Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
avkr@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Shekhar Gupta |
| Designation |
Chief Executive Officer |
| Affiliation |
D2L Clinical Solutions Pvt.Ltd. |
| Address |
1st Floor, Nandi Infotech, Plot no.8, 1st Cross, Sadarmangala
Industrial Area, ITPL Whitefield Road
Bangalore
KARNATAKA
560048
India |
| Phone |
08030850666 |
| Fax |
080-30850667 |
| Email |
shekhar@d2lclinical.com |
|
|
Source of Monetary or Material Support
|
| Sponsor (Laila Nutraceuticals) |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
Survey No 181/2, 181/3, 181/4B JRD TATA Industrial Estate,
Kanuru,Vijayawada-520007 |
| Type of Sponsor |
Other [Nutraceutical Supplements Manufacturer] |
|
|
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 Annapoorna Bhat |
Sri Venkateshwara Hospital |
#86, Hosur Main Road, Madiwala, Bangalore 566068
Bangalore
KARNATAKA |
9886399730
sampoornhealthcare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Osteoarthritic Knee Joint Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LI13000 |
2 capsules twice daily (each capsule contains 250 mg of a commercial extract of Boswellia serrata gum resin) Frequency:BD, Duration:60 Days, Route of administration: Oral |
| Intervention |
LI13019F1 |
Dose: 2 Capsule twice daily (each capsule contains 100 mg of novel herbal formulation LI13019F1).
Frequency: BD,
Duration: 60 Days,
Route of Administration: Oral. |
| Comparator Agent |
Placebo |
Dose: 2 Capsules twice daily (each capsule contains excipients QS without LI13019F1 and LI13000 but resembles LI13019F1 and LI13000 capsules in weight and all organoleptic characteristics)
Frequency: BD, Duration: 60 Days, Route of Administration: Oral. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Ambulatory, male and female subjects 30 – 65 years of age with a Body Mass Index (BMI) of approximately 18 to 29.9 kg/m2.
• Only non–osteoarthritic subjects with radio graphic evidence by Kellgren - Lawrence grade 0.
• Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
• Results of screening should be within normal range or considered not clinically significant by the Principal Investigator.
• Subjects having mild-to-moderate pain in knee joint upon completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk Test, and otherwise no knee pain at rest.
• Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
• Willing to sign the informed consent and comply with study procedure. |
|
| ExclusionCriteria |
| Details |
• Subjects with any possible signs/ indications/ history of arthritis, joint disorders including dislocations and quadriceps tendons tear.
• History of underlying inflammatory arthropathy or severe RA or OA.
• Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders.
• Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
• Expectation of surgery during the study duration period.
• Female subjects, who are pregnant, breast feeding or planning to become pregnant.
• Subject having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
• Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
• History of Gout.
• Have taken any corticosteroid, indomethacin, glucosamine+ chondroitin, within 3 months prior to the Treatment Period, Visit 1 or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period.
• History of congestive heart failure or any vascular conditions.
• Subjects with HIV Positive status.
• Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic diseases, or malignancies, hypothyroidism.
• History of Systemic Lupus Erythematous (SLE).
• High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
• History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
• Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
• Have taken acetaminophen / paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the Screening Visit. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in 80 meter Fast-Paced walk test |
Day 1, Day 7, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement from baseline to end of the trial period in :
• 30 sec Chair Stand Test
• VAS
• WOMAC A (Pain), WOMAC B (Stiffness) and WOMAC C (Physical function) scores
• Primary Knee flexion range of motion.
Endpoints for Safety
• Adverse events (AEs), frequency and severity.
• Proportion of subjects who discontinue study treatment due to adverse events.
• Changes in vital parameters. |
Day 1, Day 7, Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Eligible
healthy subjects in the age group of 30-65 years of both genders will be
randomized into 1:1:1 and will be assigned to either study medication or
placebo or comparator. The study medication is a novel herbal formulation with
known health benefits and has been used as the Ayurvedic and Herbal remedies in
India since long time. The comparator product is a commercial extract of
Boswellia serrata. Subjects
having mild-to-moderate pain in knee joint will be enrolled into this study
after assessing inclusion-exclusion criteria mentioned in the approved study
protocol. The purpose of this study is to assess the clinical effectiveness and
safety of the novel herbal formulation vs. Placebo vs. comparator in reducing
knee joint pain and other associated symptoms in healthy individuals. The total
study duration is 60 days comprising five clinical visits including three
times blood testing at different intervals. Physical examination and adverse
event information will be assessed at each visit. |