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A Study On Effectiveness of Chitrakadi Churna and Lifestyle changes in improving Prediabetes with Special references to HbA1C.

A Randomized Clinical Study To Evaluate Efficacy Of Chitrakadi Churna & Lifestyle Management In Prediabetes With Special References To HbA1C. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083382
Enrollment
82
Registered
2025-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

None listed

Sponsors

Dr Hetalben Patel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Newly diagnosed patient with Prameha Purvarupa w.r.t prediabetes. i.e. -HbA1c- 5.7-6.4% or -FBS- 100-125 mg/dl or -PPBS- 140-199 mg/dl. 2)Subjects of age group between 20-70yrs (20-70 both inclusive) will be in the inclusive. 3)Both males and females (female- non-lactating and not pregnant) will be in the inclusion. 4)Written consent showing willingness to participate in the study. 5)The patient will be taken according to American Medical Association Criteria for diagnosis of Diabetes Mellitus.

Exclusion criteria

Exclusion criteria: 1)Age under 20 years and over 70 years. 2)Type-II DM (NIDDM) with and without complications 3)Type-I DM (IDDM) associated with and without complications 4)Known cases of Diabetes due to endocrinopathies, for example, pheochromocytoma, acromegaly, Cushing s syndrome, etc. 5)Patients having disorders like carcinoma anywhere in the body or any other major life-threatening disease. 6)Known cases of drug or chemical-induced DM, such as glucocorticoids, thyroid hormone, thiazides, phenytoin, etc. 7)Known cases of Certain genetic syndromes sometimes associated with DM, e.g., Down s syndrome, Klinefelter s syndrome, Turner s syndrome, etc.

Design outcomes

Primary

MeasureTime frame
Reduction in HbA1C levels from baseline, indicating improvement in glycemic control among prediabetes individualsTimepoint: follow up will be 30 days for 3 months (90 days)

Secondary

MeasureTime frame
reduction in BMI, indicating weight management improvement as part of lifestyle intervention. improvement in waist to hip ratio.Timepoint: measures before the start of intervention at day 0 and final measurements at day 90 to assess changes

Countries

India

Contacts

Public ContactDR HETALBEN M PATEL

Padmashree Dr D Y Patil school of Ayurveda,Nerul,thane,Navi Mumbai.

neena.damle@dypatil.edu7977153510

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026