A comparative safety and efficacy evaluation of different formulations on Healthy Subjects with Spondylitis Difficulties.
- Registration Number
- CTRI/2021/12/038614
- Lead Sponsor
- Akay Natural Ingredients Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects with known history of spondylitis difficulties
2.Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study
3.Must be willing and able to give informed consent and comply with the study procedures.
1.Subjects with any chronic, acute ailments or with any other diagnosed disorders and under medications.
2.Subjects having symptoms of viral infection, including COVID-19 infection
3.Subjects on ongoing treatment for spondylitis with steroids, TNF-alpha inhibitors, etc
4.Subjects on other therapies such as homeopathy / Ayurveda
5.Subjects allergic to herbal products or any component of the study product
6.Known HIV or Hepatitis B positive or any other immuno-compromised state
7.History of clinically significant comorbidity
8.Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation
9.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
10.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Spondylitis Disease Activity Index scores and inflammatory markersTimepoint: Day 0, Day 14 , Day 28, Day 42
- Secondary Outcome Measures
Name Time Method Change in Anti oxidant and other laboratory parametersTimepoint: Day 0, Day 14 , Day 28, Day 42;overall safety of the investigational productsTimepoint: Day 0, Day 14 , Day 28, Day 42