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efficacy of Shuddhi Dr. Sukoon Tablets in patients having Stress Issues.

An open Label, Single arm Clinical Study to Evaluate the efficacy of Shuddhi Dr. Sukoon Tablets in patients having Stress Issues. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/091819
Enrollment
35
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: F430- Acute stress reaction

Interventions

Intervention1: Test Product: Shuddhi Dr. Sukoon Tablets: Dose: 1-1 Tablet (BD) Route of Administration: Oral Duration: 30 days. Control Intervention1: Not Applicable: Not Applicable

Sponsors

Jeena Sikho Lifecare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject from 18-65 years of age. 2. Subject suffering from one or multiple mental health Issues from- anxiety, insomnia, mood disorder etc. 3. Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study. 4. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids. 2. Subjects that have participated in any other interventional clinical trial in the previous 90 days. 3. Subjects with known sensitivity to any of the constituents of the investigational product. 4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 5. Chronic illness which may influence the outcome of the study. 6. Pregnant/nursing mothers

Design outcomes

Primary

MeasureTime frame
1. SGA(Subject Global Assessment) score 2. EEG Score 3. Change in mental QOL Score (DASS-21). Timepoint: Day 1, Day 15, Day30

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactPuneet Mittal

CCFT Laboratories

puneetmittal@mgcts.org8937015757

Outcome results

None listed

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