Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Sahyadri Ayurvedic Life Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 2. Type 2 diabetes subjects (diagnosed clinically) = 6 months prior to screening. 3. HbA1c = 7.0 % and = 10.0 % (both inclusive). 4. Subjects willing to give written informed consent. 5. Subjects able to comply with the study protocol. 6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry. 7. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
Exclusion criteria
Exclusion criteria: 1. Suspected or confirmed pregnancy. 2. Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.) 3. Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.) 4. Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.) 5. Any form of prescription medication. 6. Use of antibiotics in the three months prior to enrolment. 7. A direct or familiar relationship with the Sponsor, Investigator, or site personnel affiliated with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Change in level of HbA1c from baselineTimepoint: Day 0 To Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in BSL valuesTimepoint: Day 0 To Day 90;• Change in lipid panel test valuesTimepoint: Day 0 To Day 90;• Change in patient reported outcome for weight increase/ decrease, hunger and thirst and frequent urination at various follow up appointmentsTimepoint: Day 0 To Day 90 | — |
Countries
India
Contacts
Public ContactDr Shailesh Malekar
Alchemy Clinical Research Services
Outcome results
None listed