Efficacy of Trivanga Bhasma with Nisha Aamalaki churna in Diabetes Mellitus

Pharmaceutico-Analytical Study of Trivanga Bhasma and re-evaluation of its Clinical efficacy along with Nishamalaki Churna in the management of Madhumeha (Type II Diabetes) - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067627

Enrollment

Registered

2024-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Both the sexes having age between 30 to 60 years. 2)Diagnosed case of Insulin Resistant Type II Diabetes. 3)Patients having raised BSL or HbA1C, with or without among chief complaints of Madhumeha (Prabhuta- Avilamutrata, Pipasadhikya, Kshudhadhikya etc.) 4)Known patient of Type II Diabetes and also the preliminarily diagnosed patients on the basis of signs and symptoms of the disease are confirmed by FBS and PPBS. 5)Patients having Fasting blood sugar level =126 mg/dl and =200 mg/dl and or PPBS level =200 mg/dl and =350 mg/dl.xxiii 6)Patients on conventional (Allopathic) oral hypoglycemic agents with and without medications for management of diabetes unchanged(antidiabetic management protocol) over period of last 3 months.

Exclusion criteria

Exclusion criteria: 1)Age more than 60 and below 30 years. 2)All patients of diabetes mellitus receiving insulin. 3)Patients having Fasting blood sugar level less than 126 mg/dl and more than 200 mg/dl and or PPBS level less than 200 mg/dl and more than 350 mg/dl. 4)Malignant and accelerated hypertensive. 5)Patients having chronic complications of Diabetes Mellitus ,Microvascular: Nephropathy,Macrovascular: Coronary artery disease (Acute or recent MI), Acute Peripheral vascular disease & Acute Cerebro-vascular episode. And acute complications like Prameha Pidaka (non-healing wound), extensive Localized or systemic virulent infection, Diabetic ketoacidosis.Other chronic debilitating diseases like STD etc,HIV positive cases,Secondary Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Re-evaluation of efficacy. Evaluation of duration response relationship on glycemic control. Timepoint: Baseline,From 1st week to 24 weeks fortnightly	—

Secondary

Measure	Time frame
Enrichment of data of standardization. Documentation of clinical safety. Timepoint: 36 weeks	—

Countries

India

Contacts

Public ContactDr Prashant Bedarkar

ITRA Jamnagar

drprashantbedarkar@gmail.com8128217370

Outcome results