Effect Of Nishamalaki And Chandraprabha Vati In Management Of Diabetic Patients

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/02/017423
• Lead Sponsor: Chaudhary Brahm Prakash Ayurveda Charak Sansthan

Brief Summary

This trial is conducting for the purpose of MD dissertation award.Diabetes Mellitus is a group of common metabolic disorders that share the phenotype of hyperglycemia. Depending on the etiology of the Diabetes Mellitus factors contributing to hyperglycemia include reduced insulin secretion increased insulin resistance leading to decreased glucose utilization. Diabetes itself is not a fatal disease but it is hazardous to health due to its complications. Describing the Prameha, it has been mentioned that it is a group of disorders in which there is increased frequency of micturition, the volume of urine is also increased and the urine becomes turbid. Acharyas have explained that in Madhumeha there is vitiation of Vata Kapha Pradhana Tridosha associated with Meda and other Dhatus along with Ojas asDushya which comes out of the body through Mutravahasrotas. Diabetes prevalence is increasing rapidly previous 2013 estimates from the International Diabetes Federation put the number at 381 million people having Diabetes. The number is projected to be almost double by 2030. in this comparative study to evaluate the efficacy of Nishamalaki Churna and Chandraprabha vati in Madhumeha. STUDY DESIGN- Single centered, open label, randomized control study, efficacy study,with one of active control without any crossover.  STUDY AREA  OPD & IPD of Ch. Brahm Prakash Ayurveda CharakSansthan,KheraDabar, New Delhi. STUDY POPULATION:Diagnosed patients of Type-2 Diabetes Mellitus will be selected for this purpose on the basis of inclusion criteria.INCLUSION CRITERIA  Patients with age between 40-60yrs Sex:Both male and female  Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION. FBS-126-200mg/dl PPBS-200-350mg/dl HbA1c-6.5-10% Patients taking any type of oral anti-diabetic treatment.  EXCLUSION CRITERIA:Patients below the age of 40 years and more than the age of 60 years Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl  Post Prandial Blood Sugar Level <200 mg/dl and >350 mg/dl  HbA1c <6.5%. Patients depending on the insulin for blood glucose control. Patients with diabetic complications. Patients suffering from Secondary Diabetes.Gestational diabetes. Pregnant ladies and lactating mothers.

GROUP A(TRIAL GROUP)  NishamlakiChurna - 6gm twice in a day for 21 days with lukewarm water.

GROUP B(COMPARATOR GROUP)  Chandraprabha vati18– 500 mg twice in a day for 21 days with water. assessment criteria is symptoms of Madhumeha and FBS PPBS  and assess on day0 day1, day7 and day14, day 21 primary outcome is FBS AND PPBS  and secondary outcome is HbA1c.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-02
• Study Start: 2019-10-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION FBS 126 to 200mg/dl PPBS 200 to 350mg/dl HbA1c 6.5 to 10% Patients taking any type of Oral anti diabetic treatment.

Exclusion Criteria

• Patients below the age of 40 years and more than the age of 60 years Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl Post Prandial Blood Sugar Level <200 mg/dl and >350 mg/dl HbA1c <6.5%.
• Patients depending on the insulin for blood glucose control.
• Patients with diabetic complications.
• Patients suffering from Secondary Diabetes.
• Gestational diabetes.
• Pregnant ladies and lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FBS	DAY0 day1 day7 day14 day21
PPBS	DAY0 day1 day7 day14 day21

Secondary Outcome Measures

Name	Time	Method
HbA1c	day0 day1 day7 day14 day21

Trial Locations

Locations (1)

Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi 110073; 🇮🇳 Delhi, DELHI, India

Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi 110073

🇮🇳Delhi, DELHI, India

Garima kashyap

Principal investigator

8800831402

garimakashyap1810@gmail.com