A Controlled parallel-group clinical study to assess the effect of a Bacillus coagulans-based product on immunomodulation and stress levels
- Registration Number
- CTRI/2020/07/026453
- Lead Sponsor
- Abode Biotec India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy male/female of age 18-65 years.
2.FBG (� 126 mg/dl).
3.Normal blood parameters (Hb � 10 g/dl).
4.Subjects who understand the nature and purpose of the study
including the potential risks and side effects.
5.Subjects who are willing to complete all study procedures
including study related questionnaires and comply with study
requirements.
6.Subjects who have given voluntary, written, informed consent to participate in the study.
1.Women who are pregnant or Lactating.
2.Subjects who are taking Antibiotic treatment
3.Subjects suffering from Gastrointestinal disease
4.Subjects suffering from Diabetes
5.Subjects suffering from Chronic/iatrogenic
immunodeficiency
6.Subjects suffering from Abnormal blood pressure
7.Subjects who are allergic to ingredients of the study
product
8.Subjects who are using any other pre/pro/symbiotic
product.
9.Subjects who are Smoker or alcoholic
10.Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method