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A Clinical trial to study the effect of SDLSNT21 tablet in Patients of Nidranash(Insomnia).

â??A randomized double-blind controlled clinical study to evaluate the efficacy of SDLSNT21 in the management of Nidranash (insomnia).â??

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049355
Enrollment
90
Registered
2023-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: G470- Insomnia

Interventions

None listed

Sponsors

Dean Faculty of Ayurved
Lead Sponsor
Solumiks Herbaceuticals Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients having Classical Lakshana of Nidranash like Angamarda, Shirogaurava, Jrumbha, Jadyata, Glani, Bhrama, Apakti, Tandra. 2. Diagnosed case of insomnia made according to the guidelines mentioned in DSM-V for 3 month and above. Patient ready to give inform consent and abide instruction.

Exclusion criteria

Exclusion criteria: 1 Patient below 20 years & after 60 years. 2 Insomnia secondary to Major mental disorders. 3 Pregnant and Lactating women. 4 Patient with RTA, Alcoholism. 5 Patient with drug dependency like anti-histamines and narcotics. Patient with severe pain and orthopnea, Uncontrolled DM & HTN. Patient having chronic illness like IHD, COPD, Malignancies and other Medical conditions.

Design outcomes

Primary

MeasureTime frame
Assessment on the basis of gradation of classical symptomes of Nidranash.Timepoint: At baseline,on 15th day and on 30th day.

Secondary

MeasureTime frame
Assessment on the basis of Pittsburgh Sleep Quality Index .Timepoint: At baseline,on 15th day and on 30th day.

Countries

India

Contacts

Public ContactDr Rinjin G Krishna

Parul Institute of Ayurved

manu.r260022@paruluniversity.ac.in9481328930

Outcome results

None listed

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