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

ABSTRACT

ConditionHealth Condition 1 B972- Coronavirus as the cause of diseases classified elsewhere

InterventionIntervention1 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 ´ 600mg and Tribhuvankirtirasa ´ 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

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

CriteriaInclusion 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.



Exclusion criteria 1. Patients with known history of Diabetes Mellitus

2. Patients having difficulty in swallowing oral medications.

3. AYUSH system-based contraindications

4. Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria

(i) Respiratory distress at room ambience (Greater than or equal to 30 breaths per min)

(ii) Oxygen saturation at rest less than or equal to 93 percent (peripheral digital oxymeter) and requiring oxygen support for over one hour to normalize

(iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure.

5. Patients who have participated in other clinical trials within last 1 month;

6. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study

7. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.

8. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening

9. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.

10. Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study

11. Allergies, known to be allergic to Investigational Products (Ayurvedic Formulations)

12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol