A comparative clinico-experimental evaluation of Rasayana Drugs administered orally & by Basti in the management of Madhumeha w. s. r. to Type-II Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- blood sugar reduction and reduction in sign and symptoms of diabetes mellitus type 2
Study Overview
Brief Summary
In present clinical trial patient fulfilling inclusioncriteria wererandomly divided into three groups viz; group A in which Madanaphala TailaAnuvasana 160 ml followed by threeRasayana Basti each of 9 Prasruta (850ml) & one Anuvasana on last day; in aschedule of 21 days was given; second group B inwhich Rasayana Kashaya in adose of 100ml daily in two divided doses beforemeal for 21 days was given & in group C placebo capsule of500 mg twice a day for 21 days was given. Total 91 (91%)patients, i.e. 30 in group A, 30 in group B and 30 in group C completed thecourse of the therapy. Rasayana Basti hasshown 54.55% decrease in polyurea, 50% in turbidity of urine, 53.49% inpolyphagia, 60.87% in polydypsia, 90.91% in leg cramps, 69.57% in burningsensation, 68.75% in numbness, 58.54% in excess sweating, 75% in dryness ofmouth, 65.52% in the weakness, 67.57% in fatigue, 1.72% in the weight loss& 55.56% in the loss of libido. Rasayana Kashaya has shown 54.90% decreasein polyurea, 50% in turbidity of urine, 52.38% in polyphagia, 60% inpolydypsia, 72.22% in leg cramps, 57.58% in burning sensation, 55.56% innumbness, 50% in excess sweating, 100% in dryness of mouth, 58% in theweakness, 65.52% in fatigue, 1.02% in the weight loss & 50% in the loss oflibido. Placebo failed to give any relief however the symptoms aggravated bythe placebo treatment. In patients treated with Rasayana Basti there was adecrease of 5.4% & 6.36% in FBS & PPBS respectively. These changes werestatistically insignificant (p>0.05). In group B there was a statisticallysignificant (p<0.05 & p<0.01 respectively) decrease of 13.02% &21.60% in FBS & PPBS respectively. In group C there was a statisticallyinsignificant (p>0.05) increase of 8.22% in FBS. However, in PPBS 20.62%increase was seen which was statistically significant (p<0.01). Results suggest that Rasayana Kashaya is superior in glycemic control as compared to RasayanaBasti. However clinical manifestations of Madhumeha are well managed with both Rasayana Basti & Kashaya
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient of NIDDM with blood sugar level, FBS- 126 to 220 mg/dl or PPBS- 180 to 300 mg/dl.
Exclusion Criteria
- •Patients having age less than 20 years & above 60 years.
- •Patients of Type-I Diabetes or the patients of Type-II Diabetes taking Insulin.
- •Patients having complications of Diabetes like Nephropathy, Retinopathy, Diabetic Foot, Carbuncles etc.
- •Patients having Diabetes in association with other endocrinopathies like Phaeochromocytoma, Acromegaly, Cushing’s syndrome, hyperthyroidism etc.
- •Patients having drug or chemical induced Type II Diabetes, like glucocorticoids induced or thyroid hormone induced etc.
- •Patients with genetic syndromes associated with Type II Diabetes like Down’s Syndrome, Klinefelter’s Syndrome, Turner’s Syndrome etc.
- •Patients complicated with any Cardiovascular diseases, Renal diseases, Carcinoma or any other disease effecting multiple body systems and pregnant women etc.
- •Patients contraindicated for Bastikarma as per classics.
Outcomes
Primary Outcomes
blood sugar reduction and reduction in sign and symptoms of diabetes mellitus type 2
Time Frame: 21 days
Secondary Outcomes
- reduction in sign and symptoms of Madhumeha(21 days)