study on role of anti depression activity of ayurvedic medicines

Phase 3

• Conditions: Health Condition 1: F331- Major depressive disorder, recurrent, moderateHealth Condition 2: F331- Major depressive disorder, recurrent, moderate

• Registration Number: CTRI/2022/08/044774
• Lead Sponsor: Mahatma Gandhi Ayurveda College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Males or females between the age of 30 to 55 years.

2.Subjects who will fulfill the DSM-V criteria for the diagnosis of major depressive disorder without psychotic features and with single or recurrent episode for minimum two weeks.

3.Subjects who will be diagnosed as mild to moderate cases of MDD on Hamilton Depression Rating Scale.

4.Patients willing to give informed consent.

5.Females willing to follow methods of contraception during the course of trial.

Exclusion Criteria

1.Individuals at significant risk of suicide on the basis of the clinical judgement.

2.Pregnant, breast ââ?¬â??feeding or planning to become pregnant during the study.

3.Current history of illness with hepatic, renal, gastroenterological, respiratory, cardiovascular (including IHD), endocrinologic, neurologic, immunologic or hematological diseases and infectious diseases etc.

4.Significantly abnormal laboratory test and finding of electrocardiograph.

5.Current use of drug abuse or alcohol dependence.

6.Diagnosis of panic disorder, generalized anxiety, dementia, bipolar disorder, schizophrenia, or any other psychiatric disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
�To study the efficacy of Mansyadi Capsule on Vishaada (Major Depressive Disorder) <br/ ><br>�To study the efficacy of Jyotishmati Capsule on Vishaada (Major Depressive Disorder) <br/ ><br>�To compare the efficacy of Mansyadi Capsule with Jyotishmati Capsule on Vishaada (Major Depressive Disorder) <br/ ><br>Timepoint: assessment will be reported on baseline, 30th day, 60th day & 90th day on the basis of Hamilton Depression Rating Scale & Serum Cortisol morning 8 am sample on 0th day & 90th day

Secondary Outcome Measures

Name	Time	Method
no any secondary outcome NILTimepoint: nil