| CTRI Number |
CTRI/2020/12/029475 [Registered on: 01/12/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to determine the effect of CL20189 and CL20193 in mild to moderate COVID-19 patients |
|
Scientific Title of Study
|
A randomized, double-blind, clinical study to evaluate the effect of CL20189 and CL20193 in mild to moderate COVID-19 subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLS/CV/CL20189/20 Version 1.0 Dated 22-Sep-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Sunil Naik |
| Designation |
Associate Professor of Medicine |
| Affiliation |
Government Medical College and Government General Hospital |
| Address |
Room No 4, Ground Floor Department of Medicine, OPD Block Government Medical College and Government General Hospital
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drsunilnaikggh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Kavangula Krishna Chaitanya |
| Designation |
Head-Pharmacology |
| Affiliation |
CLS Pvt Ltd |
| Address |
Room No-201,First Floor, Pharmacology Department, Aswaraopet,
Khammam
TELANGANA
507301
India |
| Phone |
|
| Fax |
|
| Email |
krishnachaitanya.k@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ajjarapu Srinivasu |
| Designation |
Manager |
| Affiliation |
CLS Pvt Ltd |
| Address |
Room No-101,Ground Floor, Sales Department, Aswaraopet
Khammam
TELANGANA
507301
India |
| Phone |
|
| Fax |
|
| Email |
srinivasu.ajjarapu6567@gmail.com |
|
|
Source of Monetary or Material Support
|
| CLS Pvt. Ltd, Aswaraopet, Khammam District, Telangana-507301 |
|
|
Primary Sponsor
|
| Name |
CLS Pvt Ltd |
| Address |
Aswaraopet Khammam District Telangana 507301 |
| Type of Sponsor |
Other [Herbal ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Naik |
Government Medical College & Government General Hospital |
Department of General Medicine, Room No 4, Ground Floor, OPD Block
Srikakulam
ANDHRA PRADESH |
8942279033
drsunilnaikggh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government Medical College & Government General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1 |
Subjects will receive the Standard therapy along with the CL20189 (CL20189 500 mg - One capsule daily in the morning orally for 30 days) |
| Intervention |
Arm 2 |
Subjects will receive the Standard therapy along with the CL20193 (CL20193 500 mg - One capsule daily in the morning orally for 30 days) |
| Comparator Agent |
Arm 3 |
Subjects will receive the Standard therapy along with the placebo (Placebo - One capsule daily in the morning orally for 30 days) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects (from OPD/ Hospital Isolation /Quarantine ward) aged between 20-60 years with body mass index (BMI) of 22-29.9 kg/m2. Subjects confirmed as positive for Laboratory (RT-PCR) SARS-CoV-2.
Subjects with symptoms of mild illness with COVID-19 that include any of the following symptoms: fever, sore throat, cough, malaise, headache, muscle pain, gastrointestinal symptoms.
Subjects with symptoms of moderate illness with COVID-19 that include mild illness or shortness of breath with exertion or any of the following clinical signs;
Heart rate/Pulse rate: ≥ 90 beats/min
Respiratory rate ≥ 20 breaths/min
Saturation of oxygen (SpO2) > 93% on room air
Subjects willing to refrain from special diets, probiotics, taking nutritional supplements or medications known to affect immune function or absorption of nutrients during the study period.
Female subjects have a negative pregnancy test at the screening visit.
Ability to understand the risks/benefits of the protocol and willing to sign the informed e-consent.
|
|
| ExclusionCriteria |
| Details |
Subjects with severe or critical COVID-19 condition as per chest CT scan.
Subjects allergic to any of the study supplement ingredients.
Subjects with uncontrolled diabetes (RBS>140mg/dL), hypertension (Systolic >145 and Diastolic >90 mmHg).
Subjects underwent treatment for COVID-19 will be excluded.
Subjects using Immune modifying medications for last one month, Steroids- for last 03 months).
Subjects with any history of immune system disorder or auto-immune disorders.
Subjects with Pneumonia, COPD, asthma, any respiratory or breathing related disorders.
Subjects who consume alcohol (>5 drinks per week), habit of smoking, chewing tobacco, use of recreational drugs (such as cocaine, methamphetamine, marijuana etc.).
Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
Subjects with HIV Positive.
Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in time to clinical recovery including RT-PCR |
Baseline to End of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in QOL questionnaire (SF-36) |
Baseline to End of the study |
| Change from baseline to the end of the study period in Immune Function Questionnaire (IFQ) |
Baseline to End of the study |
| Change from baseline to the end of the study period in Hematology parameters |
Baseline to End of the study |
| Change from baseline to the end of the study period in Differential Leukocyte Count (DLC) |
Baseline to End of the study |
| Change from baseline to the end of the study period in Serum biomarkers (IL-6, TNF-α & IFN-γ) |
Baseline to End of the study |
| Change from baseline to the end of the study period in Specific IgM for ‘S’ protein |
Baseline to End of the study |
| Change from baseline to the end of the study period in CD4, CD8 and NK Cell population analysis |
Baseline to End of the study |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized double-blind, clinical study to evaluate the effect of CL20189 and CL20193 in mild to moderate COVID-19 subjects. The study consists of 3 arms in which subjects in arm 1 will receive the standard therapy along with CL20189, subjects in arm 2 will receive the standard therapy along with the CL20193 and in arm 3 subjects will receive standard therapy and placebo. |