A clinical trial to study the efficacy and safety of standardized Withania somnifera extract in chronically stressed subjects

Phase 4

• Conditions: Health Condition 1: null- Chronically stressed patients

• Registration Number: CTRI/2011/12/002278
• Lead Sponsor: atreon Inc Research And Development Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Subjects meeting all the following criteria will be included in the study

1.Subjects between the age group of 18 â?? 70 years of either sex.

2.Subjects who fit into either Grades 1, 2 and 3 on the Objective physical health scale (ref: Vaillant GE, Mukamal K. Successful Aging. Am J Psychiatry 2001; 158:839â??847)

3.Subjects who are stable on medications with no change in medication in the last 4 weeks and who have the results of the following investigations in the standard laboratory range (± 10%) : Hb, CBC, ESR, Urine

4.Subjects who have a mHAM-A of > 28 for physical symptoms and > 19 for cognitive/ mood/ behavioural symptoms.

5.Women should have a negative urine pregnancy test at screening and should be willing to use adequate methods of contraception (OC pills /double barrier methods) or should have no childbearing potential (surgically sterilized or postmenopausal for 1 year).

6.Subjects ready to abide by trial procedures and willing to give written informed consent.

Exclusion Criteria

Subjects presenting with any of the following criteria will be excluded from the study.

1.Subjects who are taking antidepressant, antipsychotic and anxiolytic medications.

2.Subjects with a history of intake of any herbal / ayurvedic/ homeopathic medicines for any indication. in the last one month.

3.Subjects with a presence of clinically significant laboratory abnormality at screening e.g. significant abnormality of Liver Function Test (more than 2.5 times upper limit of normal) & Renal Function Test (more than 1.5 times upper limit of normal).

4.Subjects with drug/alcohol addictions

5.Subjects who have received in the 3 months prior to screening any systemic glucocorticoid treatment.

6.Subjects with history of hospital admission (hospital stay > 24 hours) with medical/surgical complications in the last1 month.

7.Subjects with history of infectious diseases in the last 1 month

8.Subjects with any known hypersensitivity to the components of the test medicine.

9.Women who are pregnant or breastfeeding or fertile women who are not practicing adequate methods of contraception (OC pills /double barrier methods).

10.Subjects who have received any investigational drug within the previous 1 month.

11.Subjects who are simultaneously participating in any other clinical trial.

12.Subjects with any other condition which in the opinion of the investigator would make the him/her unsuitable for the study or compromise his/her safety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified