A Study on the effect of Cannabis based polyherbal formulation to reduce sleep disturbance

A SINGLE-ARM, OPEN-LABELINTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ACANNABIS BASED POLYHERBAL FORMULATION IN PATIENTS WITHINSOMNIA. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109225

Enrollment

Registered

2026-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects with complaints of Insomnia with an ISI score above 8. 2. Subjects in the age group 18 and above. 3. Subjects willing to give a written informed consent and agree to come for a regular follow-up visit. 4. Subjects diagnosed with Primary Insomnia as per standard diagnostic criteria 5. Subjects willing to abide by and comply with the study protocol. 6. Subjects who have not participated in a similar investigation in the past three months. 7. Subjects who have not taken or not using any sedatives

Exclusion criteria

Exclusion criteria: 1. Subjects who have secondary insomnia due to psychiatric or neurological illness. 2. Subjects having any active disease like severe depression, psychosis, or substance abuse that may interfere with the study. 3. Any history of underlying uncontrolled medical illness, including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness. 4. Subjects (females) who are pregnant or lactating 5. A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products. 6. Subjects who had been part of any other clinical study within 3 months before screening into the study.

Design outcomes

Primary

Measure	Time frame
To assess the effect of the cannabis-based polyherbal formulation on the severity of insomnia over the Treatment Phase & Follow-up Phase in comparison to the Baseline.Timepoint: To assess the effect of the cannabis-based polyherbal formulation on the severity of insomnia over the Treatment Phase & Follow-up Phase in comparison to the Baseline.	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Akshatha C J

Prasanna College of Ayurveda and Hospital laila beltangady

naveenmadhyam@gmail.com9633902231

Outcome results