A clinical study to evaluate Flunil ACP Capsule for treatment of Respiratory Tract Infection

Evaluation of efficacy and safety of Flunil ACP Capsules for the management of Upper Respiratory Tract Infections: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035970

Enrollment

Registered

2021-08-26

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

Health Condition 1: J069- Acute upper respiratory infection,unspecified

Interventions

Intervention1: FLUNIL ACP Capsules: The investigational product, Flunil ACP Capsules is a nutraceutical product, formulated as a capsule which has Ashwagandha Extract, Liposomal Curcumin, Honeybee Pro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects aged 18 years and above. 2. Subjects with upper respiratory tract infections similar to flu. 3. Subjects willing to provide informed written consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant, planning to become pregnant or breastfeeding women. 2. Subjects with significant medical/surgical condition which requires long-term treatment. 3. Subjects who are currently being treated with other immunostimulant drugs. 4. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months. 5. Alcohol or substance abuse 6. Allergy or sensitivity to any of the ingredients in the study treatment 7. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly. 8. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.

Design outcomes

Primary

Measure	Time frame
Serum Immunoglobulins (IgG, IgM and IgA) levels documented in the CRF at baseline, and day 30Timepoint: baseline, and day 30	—

Secondary

Measure	Time frame
Duration of upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30Timepoint: baseline, day 15 and day 30;Improvement in upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30Timepoint: baseline, day 15 and day 30;Inflammatory markers (CRP and ESR) documented in the CRF at baseline, and day 30Timepoint: baseline, and day 30;Severity of upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30Timepoint: baseline, day 15 and day 30;Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30Timepoint: baseline, and day 30	—

Measure

Time frame

Duration of upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30Timepoint: baseline, day 15 and day 30;Improvement in upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30Timepoint: baseline, day 15 and day 30;Inflammatory markers (CRP and ESR) documented in the CRF at baseline, and day 30Timepoint: baseline, and day 30;Severity of upper respiratory tract infection (URTI) documented in the CRF baseline, day 15 and day 30Timepoint: baseline, day 15 and day 30;Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30Timepoint: baseline, and day 30

—

Countries

India

Contacts

Public ContactMr Kamal Kammili

Amitojas Wellness Private Limited

cso@amitojas.com8885324455

Outcome results

None listed

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