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AYUSH 64 for accelerating the recovery in cases of Influenza

â??A Pilot Evaluation of Safety and Efficacy of an Ayurvedic Formulation (AYUSH 64) for accelerating the recovery in cases of Influenza like Illness."

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010145
Enrollment
38
Registered
2017-10-23
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: null- Patients with signs/symptoms of influenza like illness

Interventions

Intervention1: AYUSH-64: Drug:AYUSH-64 Dose:2 caps thrice daily (3 gms/day) Dosage form: Capsule Route of Administration :Oral Time of Administration : Three times a day Anupana :Water Durat

Sponsors

Central Council for Research in Ayurvedic Sciences Ministry of AYUSH GoI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex age between age 18- 65 years. 2.Voluntarily signed informed consents to participate in the study. 3.Clinically diagnosed cases of influenza like illness, having Axillary temperature >=38ºC and with at least two constitutional symptoms (headache, chills, myalgia or fatigue) and one respiratory symptom (cough, sore throat or coryza). Illness onset has to be within 36 hours.

Exclusion criteria

Exclusion criteria: 1. Aged 65yrs. 2. Cases of bronchitis, pneumonia, pleural effusion, interstitial lesions, etc. 3. Routine blood WBC is greater than the upper limit of normal; (WBC >11.0x109/L) and lesser than normal (WBC =75% 4. Patients coughing purulent sputum or with suppurative tonsillitis. 5. Patients with uncontrolled diabetes, COPD, hepatic insufficiency (ALT or AST 2 times above normal or higher); renal insufficiency (serum creatinine more than the upper lab value); chronic congestive heart failure, psychiatric diseases. 6. Have already taken antiviral drugs (amantadine, rimantadine, zanamivir and oseltamivir phosphate, etc.) or related traditional medicine after the onset /before the screening. 7. Women in pregnancy or lactation period, women of childbearing age with plan of a pregnancy. 8. Patients who are immune-compromised, such as malignant tumor, organ or bone marrow transplantation and AIDS, or taking immunosuppressant in last 3 months. 9. With dubious or confirmed alcohol and drug abuse history. 10. Suffered from acute respiratory infection, otitis media or sinusitis 2 weeks before. 11. Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before. 12. Other reasons that researchers think not fitting to participate in the study.

Design outcomes

Primary

MeasureTime frame
1.Improvement in the Influenza like illness symptoms 2.Improvement in the feverTimepoint: 0,3,7,14,21,28 days

Secondary

MeasureTime frame
1. The severity of the disease, assessed by an area under the curve (AUC) analysis of a total of ten influenza-like symptom scores, 2. Frequency of Usage of Acetaminophen/ antihistaminic/ cough syrup 3. Incidence of secondary complications of influenza like illness e.g. bronchitis, otitis media, pneumonitis etc. 4. Time to return to normal state of health and activity 5. Adverse reactions related to the intervention. Timepoint: 0,3,7,14,21,28 days

Countries

India

Contacts

Public ContactDr Manohar S Gundeti

RRA Podar Central Ayurveda Research Institute for Cancer (CCRAS)

gundetipanchakarma@gmail.com2224947822

Outcome results

None listed

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