Clinical study on Zandu Chyawanprash, Zandu Pure Honey, Trishun Tablets and Immuzan Tablets as an add to treatment of Covid 19

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: Zandu Chyavanprash: Zandu Chyavanprash include Bilva, Agnimantha, Syonaka, Patala, Gambhari, Shalaprani, Prishniparni , Brihati, Kantakari, Gokshura, Bala, Mudgaparni, Mashaparni, Karkatshringi, Tamalaki, Draksha , Jivanti, Pushkara Haritaki ,Guduchi, Vidari, Musta , Rakta Punarnava, Vasa, Kakanasika, Pippali, Sukshmaila, Riddhi &Vriddh, Meda & Mahamedha, Jivaka & Rishabhak, Kakoli & Kshir kakoli. Powder of the Following: Pippali , Vanshalochana, Tvak, Tvakpatra, Sukshmaila, Nagakesara , Amalaki, Til tail, Ghrita, Guda, Honey along with preservatives and excipients Dosage and Treatment Duration: Subjects will be given Zandu Chyavanprash in a dose of 10‐12 gm twice daily for 8 weeks Intervention2: Zandu Immuzan Tablet: Contains extract of Tulasi (Ocimum sanctum Linn.) Wh. Pl., Asvagandha (Withania somnifera Dunal.) Rt., Vasa (Adhatoda vasica Nees) Lf., Sati (Hedychium spicatum Ham. ex Smith) Rz. , Guduci (Tinospora cordifolia (Willd.) Miers.) St., Haridra (Curcuma longa Linn.) Rz. , Kantakari (Solanum surattense Burm. f.) Wh.Pl., Pippali (Piper longum Linn.) Fr., Amalaki (Emblica officinalis Gaertn.) Fr. 6 gm each Dosage and Treatment Duration: Subjects will be given Zandu Immuzan Tablet in a dose of 2 tablets twice daily for 8 weeks Intervention3: Zandu Trishun Tablet: Contains Sudarshan Churna â?? 600mg and Tribhuvankirtirasa â?? 130 mg Dosage and Treatment Duration: Subjects will be given Zandu Trishun Tablet in a dose of 1 tablet twice daily for 2 weeks Intervention4: Zandu Pure Honey: Contains honey Dosage and Treatment Duration: Subjects will be given Zandu Honey in a dose of 1 tsf twice daily for 8 weeks Intervention5: Standard care: Conventional Treatment as advised / prescribed by concerned health authorities Control Interventio CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 1. Mean time (days) required for clinical recovery from COVID‐19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms) ; 2. Comparative assessment of post‐clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups. ; Timepoint: Screening Visit (Day ‐3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56 SECONDARY OUTCOME: 1. Mean time (days) required for testing negative for SARS‐CoV‐2 ; 2. Change in duration of fever and other respiratory symptoms and WHO Ordinal scale ; 3. Changes in disease progression and requirement of Oxygen, ICU and Ventilator Support ; 4. Changes in percent mortality, post clinical recovery, lab parameters, rescue medication, health status on WHO QOL BREF ; 5. Global assessment of overall change as per the investigator and the subject ; 6. AE, SAETimepoint: Screening Visit (Day ‐3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56 INCLUSION CRITERIA: 1. Patients with mild to moderate symptoms [as per US‐CDC classification of COVID‐19 2. Clinical presentation with Laboratory (RT‐PCR or Rapid antigen or any other test for COVID19 as per current guidelines) confirmed infection of COVID‐19 3. Subjects having symptoms not more than 3 days 4. Ready to provide written informed consent for participation in the study 5. Willing to follow COVID‐19 (prevention and containment) related guidelines issued from time to time by Govt/ local health authority throughout the study period.
Epistemonikos ID: 59d29503e7b352eba4fab793a1537b8797c68da1
First added on: Feb 19, 2021