A study to evaluate the effect of Investigational Product on lower back and knee pain in physically active individuals.
- Registration Number
- CTRI/2023/03/051157
- Lead Sponsor
- Vedic Lifesciences Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 157
Participants will be included in the study if they fulfil each of the below-mentioned criteria:
1. Males & females aged 40-60 years with history of knee and/or low back pain aggravation on physical stress (squatting, walking, running, and cycling) for atleast 3 months and maximum up to 3 years.
2. BMI more than or equal to 24.9 to less than or equal to 29.9 kg/m2.
3. Participants with either of the following two criteria:
a. On screening, low back pain score more than equal to 60 on a 100 point P-NRS after completion of 4 sets of five-repetition-sit-to-stand test along with radiological evidences of lumbo-sacral degeneration indicated by 2 or more of the following:
- Loss of lordosis
- Joint space Narrowing
- Presence of osteophytes
- Bony spurs
b. On screening, knee joint pain score more than or equal to 60 on a 100 point P-NRS after completion of 4 sets of five-repetition-sit-to-stand test along with radiological evidence of knee degeneration indicated by doubtful narrowing of the joint space, possible osteophytes, or definite small osteophytes, definite narrowing of joint space.
4. Participants with a score of less than or equal to 30 on the MSK-HQ scale.
5. Moderate physical activity level as assessed by International Physical Activity Questionnaire (IPAQ)-Short form.
6. Willingness to participate in the study and comply with the study procedures and required visits.
7. Has the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed.
8. Must be literate and have the ability to complete the study-based questionnaires and tasks.
9. Ready to refrain from intake of analgesics one week prior to screening visit and during the study.
10. Female participants of childbearing age must be willing to use the accepted methods of contraception during the study.
Participants will be excluded from the study if they fulfil any of the following criteria:
1.P-NRS score more than 40 points on rest.
2.Any other type of pain except joint pain including muscular, nervine or pain due to acute injury.
3. For knee joint, participants with the radiographic evidence of no presence of OA, or multiple moderately sized osteophytes with definite JSN, sclerosis, or definite bony deformity will be excluded.
4. For lumbo-sacral joint, participants with the radiographic evidence of normal, or disc space narrowing with osteophytes, or bone sclerosis, disc space narrowing, and large osteophytes will be excluded.
5.Known cases of osteoporosis.
6.Current intake of disease-modifying osteoarthritis/antirheumatic drugs for joint pain.
7.Participants with neurological characteristic of pain (shooting, burning, stabbing, or electric shock-like pain, tingling, numbness, or a pins and needles ? feeling).
8.Participants suffering from insomnia and restless leg syndrome.
9.Participants with uncontrolled hypertension (defined as SBP more than or equal to 140 mm Hg and/or DBP more than or equal to 90 mm Hg despite anti-hypertensive treatment).
10.Participants suffering from uncontrolled type II diabetes mellitus (RBG =200 mg/dl [11.1 mmol/l] despite anti-diabetic treatment).
11.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
12.History of hyperacidity with at least one episode/week.
13.History of use of any dietary supplement within 2 weeks of screening visit.
14.Heavy drinkers defined as - for men, consuming more than 4 drinks on any day or more than 14 drinks per week and for women, consuming more than 3 drinks on any day or more than 7 drinks per weekly.
15.Participants who have any other diagnosed disease or condition, or are using any medication, that in the judgment of the investigator would put him/ her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with intervention or visits.
16.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
17.Participants who have had participated in a study of an investigational product 90 days prior to the screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method