Diabetes Mellitus, Type 2
Conditions
Brief summary
Present study entitled A Comparative Study of the Effect of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha & Metformin in the management of Madhumeha w.s.r. to Diabetes mellitus (Type II) is a small effort to find out an effective remedy for Madhumeha i.e. Diabetes Mellitus Type-2
Detailed description
Single centered, randomized clinical trial of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha was carried out on total of 60 registered patients. They were randomly classified in two groups, where in Group-A received Chhinnavahni Kashaya Vati with Agnimantha Kwatha and Group-B received Metformin for 12 weeks. Out of these, 12 patients did not complete the full course of the treatment.
Interventions
DRUGChhinnavahni Kashaya Vati along with Agnimantha Kwatha
Drug: Chhinnavahni Kashaya Vati Form : Tablet Dose: 1g TDS (2x500 mg), Before meals Mode of Administration: Oral Anupaan: 20 ml of Agnimantha Kwatha Duration: 3 Months
DRUGMetformin Hydrochloride
Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months
Sponsors
A & U Tibbia College Karol Bagh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Controlled, Parallel Group Trial.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of either sex aged between 20 to 60 years. 2. If yes in any two of the four: * Blood sugar -fasting \> 126 and ≤ 250 mg/dl. * PP \> 200 mg/dl and ≤350 mg/dl. * Glycosylated Haemoglobin (HbA1c) \> 6.5% and \< 9%. * Subjects having classical symptoms of diabetes with random glucose levels ≥200mg/dl (≤350mg/dl). 3. Diagnosed cases of Type II Diabetics having Glycosylated Haemoglobin (HbA1c) between 6.5-9% without or {with metformin in a dose1g-1.5g/day (for Group-B)}. 4. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan. 5. Subjects willing to participate and able to provide written informed consent.
Exclusion criteria
1. Age below 20 and above 60yrs. 2. Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHA's other than metformin/ any other AYUSH medication for glucose control. 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. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT \> 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects). 7. Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years). 8. Subjects who have a recent history or who are currently known to abuse of alcohol or drugs. 9. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc). 10. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. 11. Pregnant / Lactating women. 12. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy. 13. Subjects having hypersensitivity to any of the trial drug. 14. Subjects who have completed participation in any other clinical trial during the past six (06) months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OBJECTIVE PARAMETERS | Change from Baseline at End of trial [3 month] | 1\. Blood sugar fasting in Milligrams per decilitre |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUBJECTIVE PARAMETERS | Change from Baseline at End of trial [3 month] | Polyurea (excessive urine) grading from 0 to 3 |
Countries
India
Outcome results
None listed