Study of the effect of Ayurveda medicine Chhinnavahni Kashaya Vati (Ghanna Vati) and with Agnimantha Kwatha for the treatment of Madhumeha (Diabetes Mellitus -II)
- Conditions
- Health Condition 1: null- Patients of Diabetes Mellitus
- Registration Number
- CTRI/2018/06/014383
- Lead Sponsor
- Ayurvedic and Unani Tibbia College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1.Patients of either sex aged between 20 to 60 years.
2.If yes in any two of the four:
a)Blood sugar â??fasting > 126 and <= 250 mg/dl.
b)PP > 200 mg/dl and <=350 mg/dl.
c)Glycosylated Haemoglobin (HbA1c) > 6.5% and < 9%.
d)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.
1.Age below 20 and above 60yrs.
2.Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHAâ??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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A. Reduction in the values of following investigations shall be assessed. <br/ ><br>1.Blood sugar fasting (in mg/dl) <br/ ><br>2.Blood sugar post prandial(in mg/dl) <br/ ><br>3.Glycosylated Haemoglobin (HbA1c in %) â?? <br/ ><br>B. Subjective parameters will be accessed.Timepoint: Blood glucose analysis (fasting and post prandial) shall be done from â??venous blood sampleâ?? in the laboratory at baseline, 4th, 8th and 12th week. <br/ ><br>Glycosylated Haemoglobin (HbA1c in %) â?? to be assessed at the beginning and at the end of the trial <br/ ><br>subjective parameters will be assessed at baseline and end of 12th week. <br/ ><br>
- Secondary Outcome Measures
Name Time Method A. Fasting blood glucose level by prick method using glucometer <br/ ><br>B. gradings of standard Diabetes Symptom Questionnaire (DSQ) & . <br/ ><br>Symptoms as follows: <br/ ><br>1.Prabhoota mootrata <br/ ><br>2.Avila mootrata <br/ ><br>3.Kshudhaadhikya <br/ ><br>4.Pipasaadhikya <br/ ><br>5.Daurbalya/Shram <br/ ><br>6.Suptaangta/Daha <br/ ><br>7.Pindikodveshtana <br/ ><br>8.Vibandh <br/ ><br>9.Swedadikya <br/ ><br>10.Swapna sukhaTimepoint: Clinical and physiological assessment will be done before drug administration and after every two weeks i.e. <br/ ><br>DSQ and Subjective parameters along with Fasting blood sugar by prick will be accessed every visit i.e.at baseline 2, 4, 6, 8, 10 & 12 week