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AYUSH 64 for accelerating the recovery in cases of Influenza

Phase 2
Completed
Conditions
Health Condition 1: null- Patients with signs/symptoms of influenza like illness
Registration Number
CTRI/2017/10/010145
Lead Sponsor
Central Council for Research in Ayurvedic Sciences Ministry of AYUSH GoI
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
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

1.Aged <18 or >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 <4.0x109/L) or NEUT. >=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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Improvement in the Influenza like illness symptoms <br/ ><br>2.Improvement in the feverTimepoint: 0,3,7,14,21,28 days
Secondary Outcome Measures
NameTimeMethod
1.The severity of the disease, assessed by an area under the curve (AUC) analysis of a total of ten influenza-like symptom scores, <br/ ><br>2.Frequency of Usage of Acetaminophen/ antihistaminic/ cough syrup <br/ ><br>3.Incidence of secondary complications of influenza like illness e.g. bronchitis, otitis media, pneumonitis etc. <br/ ><br>4.Time to return to normal state of health and activity <br/ ><br>5.Adverse reactions related to the intervention. <br/ ><br>Timepoint: 0,3,7,14,21,28 days
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