Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Rhuleave-K: C.longa – B.serrata extract in black S.indicum seed oil 500 mg soft gel capsule once daily for 12 weeks
Control Intervention1: Placebo: 500 mg soft gel capsule once daily fo
Sponsors
Arjuna Natural Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or Female 40 to 70 years of age with 1:1 gender ratio. NRS score greater than or equal to 5 pain intensity on walking at the time of screening BMI 18 to 29 kg/m2 Doctor diagnosed OA of knee–with Kellgren–Lawrence classification grades 1-2 Willing to give voluntary written informed consent.
Exclusion criteria
Exclusion criteria: History of rheumatoid arthritis, severe osteoarthritis, gout, all other forms of arthritis, moderate or severe synovitis (KL grade 3 or over), meniscal rupture, fibromyalgia, underlying back pain, history of knee surgery, expectations of surgery in the next 4 months, and delayed onset of muscle soreness. BMI greater than or equal to 30 High alcohol intake (greater than 2 standard drinks per day) Smoking status not more than 1 pack per day. Psychotic tendencies such as schizophrenia, taking any psychotropic medicines. Psychedelic or narcotic substance use Co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease or limit normal function. Those who have a history of using glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronate, or systemic or intra-articular glucocorticoid within the past 3 months and during experiment period. Those with a history of taking anti-inflammatory drugs, boswellia, curcumin, omega-3 fatty acids, or collagen supplements within 30 days, during experiment period or who have used them chronically. Concomitant medications antibiotics, NSAIDS, steroids, OTC pills and ointments for pain 1 week before screening. Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study. Positive pregnancy, breast feeding, pregnancy planning. Subjects who have participated in a similar investigation in the past three months. Unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the WOMAC total scoreTimepoint: Baseline to D3, D5, D7, D42, and D84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in LFITimepoint: from baseline to D3, D5, D7, D42, & D84.;Mean change in McGillTimepoint: from baseline to D3, D5, D7, D42, & D84;Mean change in NRS scoreTimepoint: D1, D3, D5, D7, D42, & D84;Mean change in PRS scoreTimepoint: D1, D3, D5, D7, D42, & D84.;Proportion of subjects using rescue medicationTimepoint: from baseline to D3, D5, D7, D42, & D84. | — |
Countries
India
Contacts
Public ContactSooraj Rajasekharan Kartha
Arjuna Natural Pvt Ltd
Outcome results
None listed