Homeopathic formulation for Flu and Flu like symptoms.

Completed

Conditions: Influenza due to other identifiedinfluenza virus with other respiratory manifestations,

Brief Summary: Alleligible subjects who meet the Inclusion and Exclusion will be enrolled intothe study will have to visit the study site on screening, Day 0 (Baselinevisit) and Day 7.

200subjects will be enrolled.

Subjectsin study will receive active Investigational product and advised to take 1 vialthrice a day before food

Physicalexamination and Demographics will be recorded at screening time.

Physicalexamination and monitoring will be continuing on baseline and Day7.

Vitalswill be recorded on all visits.

Temperature will be recorded daily upto 7 days.

VisualAnalog Scale (VAS) Score on baseline and day 7

(Intensityof pain will be graded from 0-9. Pain intensity will be assessed in each case). Adverseevents will be monitored up to 7 days and will be recorded on day 1 and day 7.A buffer period of Â±1 day will be allowed for visit and beyond which it will beconsidered as a protocol deviation.

All the subjects who meet the eligibilitycriteria and have received at least one dose of study medication and had postbaseline efficacy data will be included in the efficacy analysis

All subjects who shall receive at least one doseof study

drug will be included in the safety analysis

Patient data from all the centers will be pooled

together and analyzed using paired t- test.

Recruitment & Eligibility

Inclusion Criteria

The Inclusion criteria are as follows (â€œYesâ€ to all the following will allow the subjects to be included into study) 1 Age: Adult-Above 18 years to below 60 years, both male and female 2 Willing to sign written inform consent 3 Patients recently diagnosed with Flu, the following signs and symptoms Diagnosis of Mild to Moderate Headache, Body ache and other symptoms of cough cold.
Sore throat.
Sneezing/ Nasal irritation.
Runny nose.
With or without low grade fever (<102 F).

Exclusion Criteria

The exclusion criteria are as follows (â€œYesâ€ to any one of the following will allow PI to exclude the subject from enrolling into the study 1 Upper Respiratory Tract Infections (URI or URTI) including rhinitis, sinusitis, pharyngitis, tonsillitis, laryngitis, tracheitis and otitis media.
2 Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia and acute bronchitis.
3 Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema 4 Bronchial Asthma 5 H/o Pulmonary Tuberculosis 6 Tumours of larynx, bronchi, and lungs 7 Drug-induced Cough (e.g., ACE Inhibitors) 8 Diabetes Mellitus, Hypertension 9 Known cases of severe hepatic, renal or cardiac ailments 10 H/o addiction (smoking, alcohol, drugs) 11 K/h/o hypersensitivity to herbal extracts or dietary supplements 12 Pregnant women, lactating women and women of child-bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.

Primary Outcome Measures

Name	Time	Method
Symptomatic relief from clinical symptoms of Flu and Flu like symptoms	7 Days

Secondary Outcome Measures

Name	Time	Method
To assess the safety profile of Anacosinum pellets in Flu and overall compliance to the drug treatment.	7 Days

Locations (3): Dr Girish K Kulkarni Clinic
🇮🇳
Thane, MAHARASHTRA, India
SANJIVANI CLINIC
🇮🇳
Thane, MAHARASHTRA, India
Siddhivinayak Clinic
🇮🇳
Thane, MAHARASHTRA, India
Dr Girish K Kulkarni Clinic
🇮🇳Thane, MAHARASHTRA, India
Dr Girish Kulkarni
Principal investigator
917400407195
drgirishkkulkarni@gmail.com