Multicentric clinical trial to treat immune deficiency patients with Manda Koso.

A Multicentric, Randomized, Double Blind, Parallel Group, Two Arm, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Manda Koso versus Placebo in patients with immune deficiency.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051394

Enrollment

Registered

2023-04-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: D849- Immunodeficiency, unspecified

Interventions

Intervention1: Manda Koso: One sachet of Manda Koso twice a day around same time for 90 days Control Intervention1: Placeo: One sachet of Placebo twice a day around same time for 90 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged between 18 and 65 years (both inclusive). 2. Subjects with CD4 count 300 to 700 cells per cubic millimeter. 3. Subjects with (Immune Status Questionnaire) ISQ Score is = 6. 4. Subjects with Non-alcoholic grade -I Cirrhosis OR Latent TB OR Hypothyroidism OR HIV will be included in the study. OR Subjects with history of Non-alcoholic grade - I Cirrhosis OR Controlled Type 2 DM OR Latent TB OR Hypothyroidism OR HIV for at least 2 months will be included. 5. Written, signed and dated informed consent obtained from patients before performing any study related procedures. 6. Subjects willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Subjects having history of hypersensitivity to any of components of the formulation. 2. Subjects having history of allergy to any of soy, sesame and walnut or other components of the formulation. 3. Subjects with history of uncontrolled diabetes mellitus, unstable angina pectoris, and myocardial infarction (MI). 4. Subjects with HbA1c = 8%. 5. Subjects with AIDS. 6. Subjects taking steroid treatment. 7. Subjects with terminal illness. 8. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. 9. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. 10. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.

Design outcomes

Primary

Measure	Time frame
Mean change in CD4, CD8 count, CD4:CD8 ratio from baseline to end of the study visit.Timepoint: Mean change in CD4, CD8 count, CD4:CD8 ratio from week 1 to week 13.	—

Secondary

Measure	Time frame
1. Mean change in interferons gamma from baseline to end of the study visit. 2. Mean change in Interleukins-12 from baseline to end of the study visit. 3. Mean change in Quality of life (QoL) score from baseline to end of the study visit.Timepoint: 1. Mean change in interferons gamma from week 1 to week 13. 2. Mean change in Interleukins-12 from week 1 to week 13. 3. Mean change in Quality of life (QoL) score from week 1 to week 13.	—

Measure

Time frame

1. Mean change in interferons gamma from baseline to end of the study visit. 2. Mean change in Interleukins-12 from baseline to end of the study visit. 3. Mean change in Quality of life (QoL) score from baseline to end of the study visit.Timepoint: 1. Mean change in interferons gamma from week 1 to week 13. 2. Mean change in Interleukins-12 from week 1 to week 13. 3. Mean change in Quality of life (QoL) score from week 1 to week 13.

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Countries

India

Contacts

Public ContactDr Milind Gharpure

Mediclin Clinical Research

ravindra.mote@mediclincr.com8888884024

Outcome results

None listed

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