A clinical study to evaluate the efficacy, safety and tolerability of XtraBosTM (Boswellia Serrata Extract) in patients with osteoarthritis associated with hypertension or neuropathic pain, or sleep disorder.
- Conditions
- Health Condition 1: M199- Osteoarthritis, unspecified site
- Registration Number
- CTRI/2023/07/055345
- Lead Sponsor
- Dr Willmar Schwabe India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Participants of either sex aged above 35 years to 65 years
2. Participants with a score of 4 or more on the Visual Analogue Score (VAS)
3. Participants with Osteoarthritis Index (WOMAC) > 0
4. Participants with hypertension =140/90 mmHg and or neuropathic pain and or sleep disorder clinically assessed via Neuropathic Pain Symptom Inventory (NPSI) and Sleep Interference Numerical Rating Scale (S-NRS).
5. Participants with symptoms consistent with generalized pain or OA for at least six months prior to screening
6. Patients who are continuing any NSAIDS or other analgesic medication taken for any other condition including current generalized pain.
7. Participants with non-significant safety profile CBC, LFT, RFT and Lipid.
8. Participants who are able to understand written or verbal instructions and are willing to comply with all study requirements along with voluntarily willing to sign a written informed consent.
1. Participants having history of Blood and lymphatic system disorder, cardiac disorder apart from hypertension, congenital familial and genetic disorder, immune system disorder, neoplasms benign, malignant and unspecified disorder, psychiatric disorder, Renal and urinary disorder.
2. Participants having history of drug or alcohol abuse or dependence during the last six months.
3. Participants having history of known allergy to Boswellia Serrata Extract.
4. Women participant of child bearing potential who are either unwilling or unable to use and acceptable method of birth control (Such as Oral Contraceptives,
other hormonal contraceptives, or IUD’s) to avoid Pregnancy during the study period.
5. Participants who have participated in an investigational drug trial less than 60 days prior to the screening visit.
6. Participants of vulnerable group. (Children, Lactating Mother, Elderly above 80 years and Handicapped).
7. Participant likely to not be available to complete all protocol-required study visits or procedures.
8. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Sponsor physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Difference in Mean Average Daily Pain (ADP) Score using 11-point Numerical Rating Scale (NRS) <br/ ><br>2. Difference in Osteoarthritis Index (WOMAC)Timepoint: By Week 4, week 8 & week 12
- Secondary Outcome Measures
Name Time Method 1. Difference in Visual Analogue Scale (VAS) For Assessment of Generalized Pain <br/ ><br>2. Difference in total & sum score of Neuropathic Pain Symptom Inventory (NPSI) <br/ ><br>3. Difference in Mean Sleep Interference Numerical Rating Scale (S-NRS) <br/ ><br>4. Difference in Mean Global Impression of Change (GPIC) <br/ ><br>5. Difference in mean blood pressure and percent usage of NSAIDSTimepoint: By Week 4, week 8 & week 12