Study of ayurvedic medicine on disturbed sleep in diabetic patients.

Prospective Controlled phase 2 clinical study to evaluate effect of sleep on glycemic control in type 2 diabetic subject W.S.R. to Dehaprakruti. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105734

Enrollment

140

Registered

2026-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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: Male and female participants aged between 40 to 60 years31 with known case of type 2 DM HbA1c 6.5to 8.5 Participants with impaired sleep defined as a Pittsburgh sleep quality score 5 Participants having history of disturbed sleep More than 30 minutes to fall asleep and subjective total sleep time of 6.5 hours per night for at least 3 nights per week and daytime complaints associated with disturbed sleep Participants not receiving any specific treatment for sleep improvement at the time of enrolment Habitual bedtime between 8.30 pm and midnight Participants willing to participate and give informed consent

Exclusion criteria

Exclusion criteria: Participants below 40 years and above 60 years Participants with uncontrolled blood sugar level and Hba1c more than 8.5 Pregnant or breast feeding women of women or women with positive urinary pregnancy test at screening Patients with known endocrine metabolic hepatic renal cardiovascular gastrointestinal respiratory haematological or neurological illness Patients with current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia Patients who have received following medications in the period shown in parentheses: Triazolam (1 Day) Alprazolam(2 days) Chlordiazepoxide (2 days) Temezepam(2days) Estazolam (3 days) Lorazepam (3 days) Diazepam (7 days) Patients with substance dependence/abuse in the past one year or with alcohol abuse are ineligible

Design outcomes

Primary

Measure	Time frame
1. Reduction in HbA1c levels in type 2 DM subjects having insomnia from baseline 2. Improvement in Insomnia severity Index scale in Type 2 DM subjects using Jatamansi Ghana from baseline.Timepoint: 90 days	—

Secondary

Measure	Time frame
Reduction in signs and symptoms of Madhumehain Type 2 DMTimepoint: 90 days	—

Countries

India

Contacts

Public ContactDr Laxmikant G Joshi

Ayurved Mahavidyalaya Nashik

lgjoshi06@gmail.com8805548973

Outcome results