| CTRI Number |
CTRI/2021/12/038614 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative safety and efficacy evaluation of different formulations on Healthy Subjects with Spondylitis Difficulties. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamatha K |
| Designation |
Principal Investigator |
| Affiliation |
Divakar’s Specialty Hospital |
| Address |
Room No :3, Department of General Medicine, Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris,
Bangalore
KARNATAKA
560078
India |
| Phone |
990077357 |
| Fax |
|
| Email |
drmamatharameshk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
|
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
|
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O, Ernakulam, Kerala, India. |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt Ltd |
| Address |
Malaidamthuruthu P.O, Ernakulam, Kerala, India. |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mamatha K |
Divakar’s Specialty Hospital |
Room No :3, Department of General Medicine, Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris
Bangalore
KARNATAKA |
990077357
drmamatharameshk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Spondylitis Difficulties |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BOQ-0020G |
Oral administration of BOQ-0020G capsules once a day for 42 days |
| Intervention |
CUQ1720 |
Oral administration of CUQ1720 capsules once a day for 42 days |
| Intervention |
CUQ1720-BOQ-0020G |
Oral administration of CUQ1720-BOQ-0020G capsules once a day for 42 days |
| Comparator Agent |
Placebo |
Oral administration of Placebo capsules once a day for 42 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 subject’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
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Spondylitis Disease Activity Index scores and inflammatory markers |
Day 0, Day 14 , Day 28, Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Anti oxidant and other laboratory parameters |
Day 0, Day 14 , Day 28, Day 42 |
| overall safety of the investigational products |
Day 0, Day 14 , Day 28, Day 42 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a randomized (3:1), double-blind, four arm, active-controlled clinical study. Subjects with spondylitis difficulties meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After screening, the enrolled subjects will be randomized into 4 groups: 3:1 as the healthy experimental and placebo groups. First three experimental groups will be supplemented with CUQ1720 , BOQ-0020G and CUQ1720-BOQ-0020G capsules respectively once a day for 42 days. subjects in the fourth group will receive placebo capsules.Subjects will be requested to fast for at least 10 hours before each visit and maintain their typical diet, physical activity, and general lifestyle throughout the study. The blood samples will be collected for laboratory assessments . Subject will be administered with spondylitis specific questionnaire to evaluate the disease severity. The study is planned to be conducted in 4 visits over a period of 42 days
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