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Randomized Assessor Blinded Academic Trial to Assess Role of Probiotics as Adjuvant Antidepressants

Clinical Outcome of Probiotics as Adjuvant Antidepressant an Assessor Blinded Randomised Academic Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069487
Enrollment
90
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: G- Mental Health

Interventions

Intervention1: PROBIOTIC: THREE ARMS ONE WITH ANTIANTIDEPRESSANT ONE WITH ANTIDEPRESSANT PLUS SSP PROBIOTIC ONE WITH ANTIDEPRESSANT PLUS MSP PROBIOTIC Intervention2: Probiotics : VIZYLAC GG : Contai
6 Billion CFU per capsule
1 Capsule to given once daily for 30 days SPORLAC PLUS: Each capsule containing not less than 2.5 BILLION CELLS EACH OF LACTOBACILLUS ACIDOPHILLUS (R0052) LACTOBACILLUS RHAMNOSUS(R0011) BIFIDOBACT
1 Capsule to be given once daily for 30 days Control Intervention1: Tab Escitalopram 10 mg: 1 Tablet Escitalopram 10 mg to be given once daily for 30 days

Sponsors

Aaryaman Chatterjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Drug naive/ Relapse with a minimum of 3 months without medication Prescribed T Escitalopram

Exclusion criteria

Exclusion criteria: Taking Antibiotics currently or in the last 1 month History of acute or chronic inflammatory conditions Antidepressants other than Escitalopram

Design outcomes

Primary

MeasureTime frame
To determine the clinical outcome in patients receiving only anti depressants, SSPs plus antidepressants , MSP plus anti depressant To compare effect of probiotics on each symptom dimension of DepressionTimepoint: 1 MONTH

Secondary

MeasureTime frame
Compare the change in level of inflammatory markers (CRP) after 1 monthTimepoint: 1 MONTH

Countries

India

Contacts

Public ContactAaryaman Chatterjee

Lokopriypo Gopinath Bordoloi Regional Institute of Mental Health

vijaygogoi50@gmail.com8135848178

Outcome results

None listed

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