Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1-Patients of either sex aged between 20-65 years 2-If yes in any two of four : Blood sugar fasting- 125 - 150 mg/dl. PP- 199-250 mg/dl. Glycosylated Haemoglobin (HbA1c) 6.4% - 7.5% Subjects having classical symptoms of diabetes with random glucose levels >=200mg/dl ( 3-Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.(only type 2 DM patients) 4-Subjects willing to participate and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1-Subject on any other AYUSH medication for glucose control. 2- Patients with type 1 Diabetes Mellitus. 3-Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment. 4-Uncontrolled Hypertensive subjects (BP with or without medication >140/90 mmHg after 5 mins of rest). 5-Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF. 6-Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years). 7-Subjects who have a recent history or who are currently known to abuse of alcohol or drugs. 8-Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc). 9-Subjects having hypersensitivity to any of the trial drug. 10- Subjects who have completed participation in any other clinical trial during the past six (06) months. 11- Pregnancy and lactating mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome would be measured by- Diabetic specific biomarker - HbA1c levels.Timepoint: At baseline and after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment will be done clinically on basis of improvement in objective. parameters like 1. Blood sugar fasting ( in mg/dl) 2. Blood sugar post prandial ( in mg/dl). Improvement in subjective parameter. 1. Prabhoota mootrata â?? Polyurea (excessive urine) 2. Avila mootrata â?? Unclear / turbid urine 3. Kshudhaadhikya -Polyphagia( excessive hunger) 4. Pipasaadhikya -Polydipsia (excessive thirst) 5. Daurbalya/Shram- Exhaustion / tiredness 6. Suptaangta/Daha -Polyneuritis (numbness / tingling/ burning of soles) 7. Pindikodveshtana - Cramps while walking/calf muscle pain 8. Vibandh- constipation 9. Swedadikya 10. Swapna sukha.Timepoint: At baseline and after 12 weeks. | — |
Countries
India
Contacts
Ayurvedic and Unani Tibbia college Karolbagh, Delhi.