Herbal formulation clinical trial for immune support

A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9633CP Tinospora cordifolia in Immune Support Adult Subjects

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023359

Enrollment

Registered

2020-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Capsule dosage form BHC9633CP: Day 0 to Day 56 dose : 500 mg capsules frequency : 3 times daily route of administration: orally duration of therapy :8 Weeks Control Intervention1: Pl

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects aged 40-70 years of age and of either sex 2. Subjects who were disposed to give consent to the study and willing for follow- 3.Subjects who are willing to sign ICF

Exclusion criteria

Exclusion criteria: 1.Children with genetic disorders, severe or chronic illnesses, congenital diseases, mentally challenged and those on other immunostimulant drugs were excluded

Design outcomes

Primary

Measure	Time frame
1.Change in TLC from baseline to end of study 2.Change in AlC from baseline to end f the study 3.Lymphocyte percentage Timepoint: Day 0 Day 28 and Day 56	—

Secondary

Measure	Time frame
1.Adverse events (AEs), frequency and severity. 2.Number of subjects who discontinue study due to adverse events 3.Changes in vital parameters and laboratory investigations. Timepoint: Day 0 Day 28 and Day 56	—

Countries

India

Contacts

Public ContactDrShubarani

Bangalore Clinical Services

dr.shubharani111@gmail.com

Outcome results