A Randomized Placebo Controlled Clinical Study to Evaluate the Role of Prameha Vijay Vati in the Management of Sthula Pramehi.

AIM AND OBJECTIVES

Primary Objective:

To evaluate the role of Prameha Vijay Vati in the management of Prameha associated with Sthaulya.

Secondary Objective:

To evaluate the effect of drug on Medo Dhatu of Sthula Pramehi.

To evaluate the safety of Prameha Vijay Vati.

PLAN OF STUDY: To fulfill the above mentioned aims and objectives, the research work will be carried out as follows: -

(a) Clinical Study: -Clinical study will be single centre, prospective study under direct supervision.

(b) Conceptual Study:-The Ayurvedic and modern literature pertaining to Sthula Pramehi vis a vis Type II Diabetes Mellitus will be compiled and reviewed critically.

RESEARCH STUDY DESIGN

STUDY TYPE: Interventional

STUDY DESIGN: Randomized

MASKING: Open label

CONTROL: Placebo Control

SAMPLE SIZE : 140

DURATION OF TREATMENT : 12 weeks

INTERVENTION: Prameha Vijay Vati

Selection of Patients:

The Patients of Diabesity fulfilling the diagnostic criteria will be selected from the OPD and IPD Department of Rajiv Gandhi Government Post Graduate Ayurvedic College Paprola, Himachal Pradesh.

DIAGNOSTIC CRITERIA

1. On the basis of Classical Features

Sthula Prameha Parikshana

Prabhut mutrata (Polyuria)

Avil mutrata (Turbidity in urine)

Pipasa adhikya (Polydypsia)

Kshuda adhika (Polyphagia/Increase in appetite)

Kar pada suptata (Numbness in palm and foot)

Sweda adhikya (Excessive perspiration)

Daurbalya (Weakness)

Alasya (General debility)

Shramam(Exhaustion)

Alpa chesta(Slow movement)

Shwasam(Breathlessness)

Sphik-stana lambanam(Extra fat on hip and breast region)

Daurgandhya(Foul smell)

2. Presence of obesity in patient of Diabetes Mellitus, i.e., Age adjusted BMI above 85th percentile (Indian standard)

Diabetes Mellitus Type II diagnosed on the basis of criteria suggested by WHO

Fasting Blood Sugar 126mg per dl

Post prandial blood sugar greater than or equal to 200mg/dl

Random blood sugar greater than 200mg per dl + clinical features of diabetes mellitus

HbA1c greater than or equal to 6.5 percent

INCLUSION CRITERIA

Patients willing for trial and ready to give written consent.

Patients of either sex with age between 35 to 70 years.

Obese patients i.e., weight is more than 20 percent excess of the desirable weight according to height, sex and age (according to annexed height and body weight table) Or Age adjusted BMI above 85th percentile (Indian standard).

Newly diagnosed drug naive patients of Type 2 Diabetes being having Glycosylated Haemoglobin (HbA1c) between 7 percent to 9 percent or known cases of Type 2 Diabetes with HbA1c 7 percent to 9 percent with maximum dose of metformin up-to 2.5gm per day.

EXCLUSION CRITERIA

Patients not willing for the trial.

Poorly controlled hypertensive patients (SBP greater than or equal to 160mm of Hg and/or DSB greater than or equal to 100mm of Hg).

Patients with FBS greater than 300 mg per dl; RBS greater than 400 mg per dl; HbA1c greater than 9 percent.

Patients having concomitant disorders like ischemic heart disease, congestive heart failure, established coronary artery disease and any other clinically significant cardiovascular disease.

Patient suffering from renal and hepatic dysfunction.

Patients suffering from major systemic illness necessitating long term treatment or long term steroids (R.A., PTB, S.L.E, malignancy).

Lactating and Pregnant women.

Patients below 35 years and above 70 years of age.

Individuals who have participated in any other clinical study during the past six months.

INVESTIGATIONS

Routine hematological Tests- Complete Haemogram, ESR.

Biochemical investigations-FBS, PPBS, HbA1c, RFT (B.Urea, S.Creatinine), TSB, DSB, SGOT, SGPT

S. Lipid Profile- S.Cholestrol, S.Triglycerides, LDL, HDL, VLDL.

Urine- Routine examination with albumin and protein and Microscopic examination.

INTERVENTION

140 Clinically Diagnosed Patients of Sthula Prameha will be divided into two Groups:

The patient selected in the clinical trial will receive on random the following:

Group I: 70 Patients will receive Metformin up-to 2500 mg per day & 2 tablets of Prameha Vijay Vati 500 mg each x 3 times /day before food with lukewarm water & Diet & Lifestyle modification for 12 weeks

Group II: 70 Patients will receive Metformin up-to 2500 mg per day and 2 tablets of Placebo 500 mg each x 3 times/day with Diet & Lifestyle modification before food with lukewarm water for 12 weeks.

Duration and route of administration

Route of Administration - Oral

Anupana – Luke warm water

Duration of Trial – 12 Weeks

Instructions:

Follow up: There will be five follow ups at 15 days interval and last follow up after completion of trial.

ASSESMENT CRITERIA –

i. Patients will be thoroughly assessed based on various subjective and objective parameters before the commencement and after the completion of trial.

ii. Scoring system will be adopted to assess improvement in various subjective parameters.

iii. A special Performa will be designed for assessment based on Ayurvedic principles and modern scientific knowledge.

iv. Patients will also be inquired about any growing feeling of physical and mental well-being after the therapy.

1. SUBJECTIVE CRITERIA

2. OBJECTIVE CRITERIA

Body Mass Index

Body Fat percent

Visceral Fat

Skeletal Muscle Percent

Resting Metabolism

Skin Fold Thickness

Biceps

Triceps

Supra iliac

Hip Circumference

Waist Circumference

Waist-Hip ratio

S. Lipid Profile

Fasting Blood Sugar

HbA1c

Discontinuation Criteria:

Failure to turn up for follow-up.

Those not following advice.

If the condition of person deteriorated during trial, he/she shall be excluded from study.

RESULT

Observations and results obtained through clinical study will be statistically analyzed and presented in the form of thesis.