Clinical Study on Beta Glucan N 163 to treat Multiple Sclerosis
- Conditions
- Health Condition 1: G35- Multiple sclerosis
- Registration Number
- CTRI/2022/05/042497
- Lead Sponsor
- ichiIn Bio Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adults aged >=21 years of age, all genders inclusive; with diagnosis/history of MS.
2.Subjects who have been on the same treatment regimen for a minimum of three months prior to enrolment and are willing to not make major changes to their standard treatment regimen until the end of the treatment period.
3.Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
4.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
1.Subjects with history that suggests possible allergic reaction to the key constituents of the investigational product.
2.Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible
3.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
4.Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interfere with the parameters of the clinical study.
5.Subjects with CKD or other diseases that impair normal kidney function.
6.Subjects with known history of clinically significant endocrine, gastrointestinal,cardiovascular,hematological,hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication.
7.Females who are pregnant or lactating or planning to become pregnant during the study period.
8.Subjects who are currently participating or have participated in a clinical trial upto 90 days prior to randomisation
9.Subjects, who in the opinion of the investigator are unsuitable for enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method