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Clinical Trials/CTRI/2022/11/047190
CTRI/2022/11/047190RecruitingNot Applicable

Association of prameha poorvaroopa in prediabetes – Cohort study

Tilak Ayurved Mahavidyalaya1 site in 1 country200 target enrollmentStarted: October 11, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
To study association between Prameha poorvaroopa and prediabetes

Study Overview

Brief Summary

Current study is a cohort study to find an association between sings and symptoms of prameha poorvaroopa and prediabetes. Patients diagnosed with HbA1C between 5.4 % to 6.7% will be enrolled.

Total 200 patients will be observed for the period of two and half years. Six monthly  total 4 follow ups will be conducted. Sign and symptoms of the patients and laboratory investigations will be assessed.

It has been predicted that more than 360 million individuals will have diabetes by the year 2030. The prevalence of type 2 DM is rising at an alarming rate.

This is predominantly because of increasing obesity and reduced physical activity in developing nations. It is estimated that every year a further 7 million people develop diabetes.

Symptoms such as increased fluid intake, thirst, dry mouth, itching of the skin, burning sensation of soles, numbness of the toes, paresthesia, and blurred vision may appear in prediabetic patients.[

Poorvaroopa of prameha are mentioned comprehensively in Ayurvedic text while only two samamya roopas of prameha are mentioned in the classics.

It is clear that poorvaroopas are given more importance. Poorvaroopa of prameha include pipasa (increased fluid intake, thirst), talu shosha or kantha shosha (dry mouth), Kara pada supata (numbness of the toes),

supatata angeshu (paresthesis), karapada daha (burning sensation of soles) along with other poorvaroopa. Therefore, this topic has been selected with curiosity to study the association of prameha poorvaroopa in prediabetic patients.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients full filling the Laboratory and Clinical screening parameters and diagnosed as prediabetes.

Exclusion Criteria

  • Diagnosed patients of Type I or Type II diabetes, Gestational Diabetes mellitus, Diabetes insipidus.

Outcomes

Primary Outcomes

To study association between Prameha poorvaroopa and prediabetes

Time Frame: assessment on every 6 month for 2 and 1/2 year

Secondary Outcomes

  • To study association between Prameha poorvaroopa and Anthropometric measurements in prediabetes.(To observe the possible effects of early diagnosis of prediabetic status in terms of prevention, aggression and complications of disease.)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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