CTRI Number	CTRI/2017/10/010145 [Registered on: 23/10/2017] Trial Registered Prospectively
Last Modified On:	09/04/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Single Arm Study
Public Title of Study Modification(s)	AYUSH 64 for accelerating the recovery in cases of Influenza
Scientific Title of Study Modification(s)	“A Pilot Evaluation of Safety and Efficacy of an Ayurvedic Formulation (AYUSH 64) for accelerating the recovery in cases of Influenza like Illness."
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Manohar S Gundeti  Address  Ist Floor, Technical Incharge, Clinical Department, RRAP CARIC, Podar Medical Campus, Dr. A. B. Road, Worli, Mumbai Mumbai MAHARASHTRA 400018 India  Phone  2224947822   Fax  02224947822   Email  gundetipanchakarma@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Manohar S Gundeti  Address  Ist Floor, Technical Incharge, Clinical Research Department, Podar Medical Campus, Dr. A. B. Road, Worli, Mumbai Mumbai MAHARASHTRA 400018 India  Phone  2224947822   Fax  02224947822   Email  gundetipanchakarma@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Manohar S Gundeti  Address  Ist Floor, Technical Incharge, Clinical research department, Podar Medical Campus, Dr. A. B. Road, Worli, Mumbai Mumbai MAHARASHTRA 400018 India  Phone  2224947822   Fax  02224947822   Email  gundetipanchakarma@gmail.com
Source of Monetary or Material Support Modification(s)	Central Council for Research in Ayurvedic Sciences Ministry of AYUSH GoI 61-65 Institutional Area Opposite D Block Janakpuri New Delhi
Primary Sponsor	Name  Central Council for Research in Ayurvedic Sciences Ministry of AYUSH GoI  Address  Jawaharlal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhavan, 61-65, Institutional Area, Opposite D Block, Janakpuri,New Delhi-110058  Type of Sponsor  Research institution
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Manohar S Gundeti  RRA Podar Central Ayurveda Research Institute for Cancer  Clinical section, CARIC, Podar Medical Campus, Dr. A. B. Road, Worli, Mumbai Mumbai   2224947822 2224947822 gundetipanchakarma@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Patients with signs/symptoms of influenza like illness
Intervention / Comparator Agent	Type  Name  Details  Intervention  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 Duration of therapy: 7 days and later follow-up of 3 weeks without drug Source of drug: IMPCL, Almora, Utarakhanda   Comparator Agent  Nil  Nil
Inclusion Criteria	Age From  18.00 Year(s) Age To  65.00 Year(s) Gender  Both  Details  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.
ExclusionCriteria	Details  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.
Method of Generating Random Sequence	Not Applicable
Method of Concealment
Blinding/Masking
Primary Outcome	Outcome  TimePoints  1.Improvement in the Influenza like illness symptoms 2.Improvement in the fever   0,3,7,14,21,28 days
Secondary Outcome	Outcome  TimePoints  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.   0,3,7,14,21,28 days
Target Sample Size	Total Sample Size="38" Sample Size from India="38"
Phase of Trial	Phase 2
Date of First Enrollment (India) Modification(s)	01/11/2017
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	will be published in the form of article
Brief Summary	Influenza like illness (ILI) refers to a wide range of viral infections, usually characterized by an increase in normal body temperature, body aches, joint pains, skin rashes and headache etc. These infections are treated symptomatically and antivirals are prescribed wherever needed along with antibiotics to prevent opportunistic or secondary infections. Many Ayurvedic formulations (Single plant, Polyherbal and herbomineral) are in practice for successful management of viral infections. Ayush-64 is a poly-herbal drug developed by CCRAS which is found to be effective in fevers of unknown aetiology, filarial lymphangitis and derangement of liver function besides its anti-malarial activity. A pilot study on safety and efficacy of AYUSH-64 in the treatment of clinically diagnosed influenza like illness will be carried at the O.P.D/I.P.D of R.R.A. Podar Central Ayurveda Research Institute for Cancer, Mumbai. The objective of the study will be to evaluate the safety and efficacy of AYUSH 64 in clinically diagnosed influenza like illness. Total 38 patients will be studied and a comprehensive assessment consisting of parameters viz. Improvement in the symptoms and fever, Frequency of Usage of Acetaminophen/ antihistaminic/ cough syrup, Incidence of secondary complications, and Time to return to normal state of health and activity etc. These findings will be documented through specially designed clinical record form & relevant conclusion will be drawn.