Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Rasayanam Enterprises
Eligibility
Inclusion criteria
Inclusion criteria: 1.Able to provide written informed consent and adhere to the study visit schedule and treatment. 2.Diagnosed with Type 2 diabetes mellitus and stable on routine medication. 3.Male or female aged 18 to 70 yrs of age. 4.Women of child bearing potential or WOCBP must be willing to use double barrier contraception for the entire study. 5.WOCBP must have a negative pregnancy test before entering the study. 6.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. 7.Participants who agree to take investigational product
Exclusion criteria
Exclusion criteria: 1.History of insulin use for more than 2 weeks within 2 months prior to the Screening Visit 2.Subjects after bariatric surgery or any gastric bypass or planning to have such a procedure during the Study 3.History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period 4.History of congestive heart failure 5.Any history of a malignancy 6.Pregnancy or breast-feeding, or intent to become pregnant during the study period 7.Known infection with human immunodeficiency virus 8.Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject’s best interest 9.Diagnosis of cancer. 10.History or presence of any medical conditions which impacts the quality of life 11.Hypersensitivity to product or placebo 12.Use of prescription medications and non-prescription medications for weight loss 13.Current diagnosis or medical history of alcoholism and drug dependence 14.Use of medications that are prohibited with the herbal products as per investigator descretion 15.Any other condition which the principal investigator thinks may jeopardize the safety of subjects with uncontrolled, unstable comorbidities 16. Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational study or is receiving other investigational agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean levels of HbA1c from Visit 1, Screening Visit Day 0 to Visit 2, End of study(Day 30)Timepoint: Day 0 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in QoL status as determined by QoLID questionnaire score from Screening Visit to End of study Day 30 2.Number & proportion of Treatment Emergent Adverse Events & Treatment Emergent Serious Adverse Event 3.Change in mean levels of basic laboratory parameters haematology from Visit 1, Screening Visit Day 0 to Visit 2, End of study Day 30Timepoint: Day 0 & Day 30 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed