Clinical Study between Amrita Guggulu & Dhatri Nisha Vati in Prameha w.s.r to Type-2 Diabetes Mellitus

Phase 3

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

• Registration Number: CTRI/2023/06/054120
• Lead Sponsor: Dr Andleev Aaftab

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Newly diagnosed patient ( <2yrs) of Prameha w.r.t

type-2 Diabetes Mellitus.

2) Subjects of age group b/w 30-70 yrs (30-70 both

inclusive) will be in the inclusive.

3) Both male and female (female- non lactating and

not pregnant) will be in the inclusion.

4) HbA1c >6.5 ( <60mmol/mol) within previous 3

months.

5) Diabetes Mellitus with F.B.S. > 126-mg%,

6) Post Prandial Blood Sugar >200mg%.

7) Written consent showing willingness to participate

in the study.

8) Patient will be taken according to American

Medical Association Criteria for diagnosis of

Diabetes Mellitus.

Exclusion Criteria

1) Subjects with Type-1 Diabetes will be in the exclusion.

2) Pregnant women, Lactating women will be in the exclusion.

3) Subjects with creatinine >1.5 will be in the exclusion

4) Fasting blood sugar >300mg% will be in exclusion.

5) Post Prandial Blood Sugar >400mg%.

6) HbA1c >9.0%( >75mmol/mol) will be in the exclusion criteria.

7) Subjects with known cases of Diabetic complications like diabetic

nephropathy, retinopathy, cardiovascular disease will be in the exclusion.

8) Subjects with history of stroke, myocardial infarction, in the last 6 months

will be in the exclusion.

9) Subjects of known cases of active infective diseases like Tuberculosis,

HIV, Hept-B will be in the exclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in the Subjective assessment criteria i.e. Excessive urination, Weakness, Excessive sleep, Excessive thrist, Lethargy, Increased hunger in Prameha (Type-2 Diabetes Mellitus)Timepoint: Follow up will be after 30 days for 3 months (90 Days)

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil