A Prospective, parallel arm randomized clinical study to evaluate safety and efficacy of HFSM-02 in reducing stress and anxiety in subjects with chronic medical condition and perceived stress - NI

Siddhayu Ayurvedic Research Fdn Pvt Ltd0 sites120 target enrollmentTBD

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Health Condition 1: F489- Nonpsychotic mental disorder, unspecified
Sponsor: Siddhayu Ayurvedic Research Fdn Pvt Ltd
Enrollment: 120
Status: Completed
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 14, 2020

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Siddhayu Ayurvedic Research Fdn Pvt Ltd

•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

•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.