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To know the effect and safety of turmeric extract capsule in healthy adults having severe knee joint pain

A prospective Double Blind, Randomized, Multi-Center, Parallel Group,Two Arm, Placebo-Controlled trial to evaluate the efficacy and safety of TurmXtra 60N (Water Dispersible Turmeric Extract) Capsule in healthy adults having Chronic Knee Joint Pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023877
Enrollment
106
Registered
2020-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: TurmXtra 60N: One Capsule per day within one hour of lunch for 90 Days Control Intervention1: Placebo: One Capsule per day within one hour of lunch for 90 Days

Sponsors

Inventia Healthcare Ltd
Lead Sponsor
Laila Nutraceuticals
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged between 18-60 years with BMI 18 to 30 kg/m2 and with chronic knee joint pain (at least past 2 months). 2.Subjects having moderate pain i.e. visual analogue score of 4 or greater in the knee joint. 3.Subjects willing to use ongoing analgesic drugs and/or anti inflammatory drug only as rescue medication until study completion. 4.Subject provides written informed consent and comes for regular follow up.

Exclusion criteria

Exclusion criteria: 1.Female subjects who are pregnant, lactating or planning to become pregnant during the study period. 2.Post-menopausal female subjects 3.Subjects who are suffering from arthritis of the knee as diagnosed over X-ray 4.Subjects who have taken more than two analgesic drugs and/or anti-inflammatory for more than three months 5.Subjects who have a history of surgery or trauma affecting the knee. 6.Impaired renal function; eGFR 7.Impaired liver enzymes 8.Presence or history of any chronic illness including but not limited to psychiatric, cardiovascular, pulmonary, neurological, hepatic, renal, metabolic, and ophthalmologic including HIV and AIDS taking regular pharmacological agents. 9.History of drug dependence or any severe co-morbid medical conditions. 10.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine/Caffeine dependence. 11.Subjects on multivitamins/herbal supplements/ any other wellness product 12.Subject who has participated in a clinical study within the last 30 days prior to entering this study. 13.Subject with hypersensitivity to any of the ingredients of the study products.

Design outcomes

Primary

MeasureTime frame
1.Change in Pain Visual Analogue Scale (VAS)Timepoint: Day 1, Day 45 and Day 90—

Secondary

MeasureTime frame
1.Improvement in 9-step Stair Climb Test 2. Improvement in 80 meter fast paced walk test 3.Primary Knee flexion 4.Biochemistry Timepoint: Day 1, Day 45 and Day 90—

Countries

India

Contacts

Public ContactMr Vijay Bhaskar

Invitro Research Solutions Pvt. Ltd

preethi@ivrs.org.in9900515364

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026