Clinical trial of HFSM-02 in reducing stress and anxiety.

Phase 2

Completed

• Conditions: Health Condition 1: F489- Nonpsychotic mental disorder, unspecified

• Registration Number: CTRI/2020/08/027076
• Lead Sponsor: Siddhayu Ayurvedic Research Fdn Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Subjects of age between 18 and 60 years

Free of psychiatric conditions other than stress

Have a score less than 15 on the World Health Organizationâ??five (WHO-5) well-being index and a score of at least 14 on the Perceived Stress Scale (PSS)

CHD patients showing one or more of the following conditions like hypertension, dyslipidemia, atherosclerotic, ischemic changes, with certain psychological stress-related complaints mainly irritation, anxiety, etc. on stable medical prescriptions.

Prediagnosed diabetes type 2 patients with HbA1c including but NMT 7.5 with certain psychological stress-related complaints mainly irritation, anxiety, etc. and on stable medical prescription

Exclusion Criteria

Subjects suffering from any chronic physical, neurological or psychiatric illness

Subjects currently undergoing active MI episode

Subjects with uncontrolled diabetes

Subjects with compromised liver or renal function test as per sole discretion of investigator that can prove the subject unfit for the trial

Subjects currently taking any herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs,

Subjects pregnant or lactating

Subjects with substance dependence

Subjects in investigators opinion not fit for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Profile of mood states (POMS-2) <br/ ><br>Depression and Anxiety Stress Scale 21 (DASS-21) <br/ ><br>Graded symptom scale for irritation, poor concentration and weak memory <br/ ><br>General Health Questionnaire â?? 28 (GHQ-28) <br/ ><br>Stress related disturbed sleep cycle index <br/ ><br>Serum cortisol levelsTimepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Daytime fatigue using Fatigue Severity Scale (FSS) <br/ ><br>Daytime mood, ability to function at work, concentration and memory at work place a graded scale. <br/ ><br>Safety parameters like CBC, LFT, KFT, lipid profile, urine routine, fasting blood sugar, PP blood sugar, ECG. <br/ ><br>Drug compliance <br/ ><br>Timepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60)