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Clinical Trials/CTRI/2025/08/092963
CTRI/2025/08/092963Not yet recruitingNot Applicable

A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale.

Not applicable1 site in 1 country90 target enrollmentStarted: August 25, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale.

Study Overview

Brief Summary

1)Title - A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale.

2)Primary Objective –To assess insomnia (Nidranash) as a complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale.

3)Methodology -

  1. APPROPRIATE STUDY DESIGN –It is a Cross Sectional study.

  2. STUDY SETTING –

A) STUDY PLACE- OPD and IPD in concern institutional hospitals.

B) STUDY DURATION –18 Months

C) STUDY POPULATION-Diagnosed patients of madhumeha of age group of 40-60 years.

4)Sample size -90 diagnosed patients of madhumeha

5)APPROPRIATE SAMPLING TECHNIQUE – Purposive sampling technique will be taken.

6)METHOD OF SELECTION OF STUDY SUBJECT

INCLUSION CRITERIA – • Age group between 40-60years. Diagnosed patients of madhumeha (diabetes mellitus).

Person having madhumeha (diabetes mellitus) for more than 5 years.

Patient will be selected Irrespective of their Gender, religion, socioeconomical class and marital status.

EXCLUSION CRITERIA – known cases of chronic kidney diseases, malignancies and major illnesses like Chronic Obstructive Pulmonary Diseases, known cases of Alzheimer disease will be excluded.

known cases of any psychomotor disorders, on antidepressants medications, on sleeping pills will be excluded.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)

Inclusion Criteria

  • •Age group between 40-60years.
  • •Diagnosed patients of madhumeha (diabetes mellitus).
  • •Person having madhumeha (diabetes mellitus) for more than 5 years.Patient will be selected Irrespective of their Gender, religion, socioeconomical class and marital status.

Exclusion Criteria

  • •known cases of chronic kidney diseases, malignancies and major illnesses like Chronic Obstructive Pulmonary Diseases, known cases of Alzheimer disease will be excluded.known cases of any psychomotor disorders, on antidepressants medications, on sleeping pills will be excluded.

Outcomes

Primary Outcomes

A Cross sectional study to assess Insomnia (Nidranash) as a Complication (Upadrava) of Madhumeha with special reference to Athen’s Insomnia Scale.

Time Frame: One day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Not applicable
Sponsor Class
Other []
Responsible Party
Principal Investigator
Principal Investigator

Dr Pavankumar Anant Pidge

PDEAs College of Ayurved and research centre nigadi pune

Study Sites (1)

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