To evaluate the efficacy and safety of the product Dr. Ortho Capsules in patient suffering from Knee pain, Stiffness in Joints, Arthritis, Bulky Shoulder And Inflammation in Joints, Acute Sports Injury, Strains & Sprain.
- Conditions
- Health Condition 1: M256- Stiffness of joint, not elsewhereclassified
- Registration Number
- CTRI/2023/03/050809
- Lead Sponsor
- Divisa Herbals Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age between 18 - 80 Years
2.Subjects suffering from knee pain and joint pain and arthritis
3.Subjects suffering from acute sports injury, strains, sprain, chronic arthritis, back pain, knee pain, and other joint pain.
4.Willingness to take part in study and able to attend all scheduled visits
5.Subjects willing to sign ICF
6.Subjects willing to refrain taking any other similar medication during the study period.
1.Pregnant, breastfeeding, subjects undergone any surgery and else taken part in any clinical trial
2.Participation in any other clinical study (device or drug) within 30 days prior to Screening;
3.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, hepatic, renal disease, congenital or any other disorder
4.Subject with abnormal lab values detected at the time of screening shall be excluded.
5.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational product.
6.Pre-existing systemic disease necessitating long-term medications.
7.Genetic and endocrinal disorder
8.Not willing to Sign the ICF or give the consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the percentage of subjects with significant symptomatic reduction of joint pain, stiffness in joints, arthritis, knee pain, bulky shoulder & inflammation in joints. <br/ ><br>2.Improvement in the VAS scoring on the successive application as compared to baselineTimepoint: Day 1 and Day 30
- Secondary Outcome Measures
Name Time Method 1.To assess the safety of Dr. Ortho Capsules <br/ ><br>2.To assess the percentage of subjects with significant symptomatic reduction of acute sports injury, strains & sprain <br/ ><br>3.Incidence of any AEs during the study <br/ ><br>4.Improvement in Oswestry Disability Index (ODI)from baseline visit to EOSTimepoint: Day 1 and Day 30