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A comparative safety and efficacy evaluation of different formulations on Healthy Subjects with Spondylitis Difficulties.

A Randomized, Double-Blinded, Active-Controlled, Parallel-Group, Comparative evaluation of Safety and Efficacy of CUQ1720-BOQ-0020G ,CUQ1720 and BOQ-0020G on Healthy Subjects with Spondylitis Difficulties.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038614
Enrollment
140
Registered
2021-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: CUQ1720-BOQ-0020G: Oral administration of CUQ1720-BOQ-0020G capsules once a day for 42 days Intervention2: CUQ1720: Oral administration of CUQ1720 capsules once a day for 42 days Interv

Sponsors

Akay Natural Ingredients Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Mean change in Spondylitis Disease Activity Index scores and inflammatory markersTimepoint: Day 0, Day 14 , Day 28, Day 42—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026