| CTRI Number |
CTRI/2021/03/031940 [Registered on: 12/03/2021] Trial Registered Prospectively |
| Last Modified On: |
03/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial for TADIOS as supplemental therapy in mild to moderate COVID-19 |
|
Scientific Title of Study
|
Multicenter, double-blind, placebo-controlled, maximum 10 days administration study to evaluate the efficacy and safety of TADIOS as an adjuvant therapy in patients diagnosed with mild to moderate COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0041-008 (Dated 25.2.2021 Version 1.0) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajkumar Nikalje |
| Designation |
Director & Consultant Chest Physician |
| Affiliation |
Oxycare Multispecialty Hospital |
| Address |
Department of Respiratory Medicine, Oxycare Multispecialty Hospital, Sr. No 84, Lakshmi nagar, Neal Bhalke Colony, Walhekarwad, Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9028560535 |
| Fax |
|
| Email |
nikalje.rajkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Gowda |
| Designation |
President and QA head |
| Affiliation |
Syncorp Health Private Limited |
| Address |
Building # 06, 3rd floor, 2nd Main Rd, opposite to British Biologicals, Sarvobhogam Nagar, Arekere
Bangalore
KARNATAKA
560076
India |
| Phone |
9972434444 |
| Fax |
|
| Email |
deepak.gowda@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Gowda |
| Designation |
President and QA head |
| Affiliation |
Syncorp Health Private Limited |
| Address |
Building # 06, 3rd floor, 2nd Main Rd, opposite to British Biologicals, Sarvobhogam Nagar, Arekere
Bangalore
KARNATAKA
560076
India |
| Phone |
9972434444 |
| Fax |
|
| Email |
deepak.gowda@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Helixmith Co., Ltd.
21, Magokjungang 8-ro 7-gil, Gangseo-gu, Seoul 07794, Korea |
|
|
Primary Sponsor
|
| Name |
Helixmith Co Ltd |
| Address |
21, Magokjungang 8-ro 7-gil, Gangseo-gu, Seoul 07794, Korea |
| Type of Sponsor |
Other [Bio products ​ Natural Bionutricals​] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhu N |
Chaitanya Hospital |
Court Side Road, North Paravur, Kochi, Kerala-683573
Ernakulam
KERALA |
04842441428
drnmadhu17@gmail.com |
| Dr Ramshyam C Agarwal |
Gunjkar Multispeciality Hospital |
Gunjkar Multispeciality Hospital, Shivtej Nagar, Chikhali, Pimpri Chinchwad, Pune-19
Pune
MAHARASHTRA |
8087282022
ramshyamagarwal20@gmail.com |
| Dr Shyam Mukundan |
Lakshmi Nursing Home |
Palace Road, Aluva-683101, Kerala, India
Ernakulam
KERALA |
8943967475
drshyammukundan@gmail.com |
| Dr Rajkumar Nikalje |
Oxycare Multispecialty Hospital |
Oxycare Multispecialty Hospital, Sr. No 84, Lakshmi nagar, Neal Bhalke Colony, Walhekarwad, Chinchwad, Pune -33
Bangalore
KARNATAKA |
9028560535
nikalje.rajkumar@gmail.com |
| Dr John Paul M |
Sparsh Super Speciality Hospital |
Sparsh Super Speciality Hospital, 4/1, Tumkur Rd, Yeshwanthpur Industrial Area, Phase 1, Yeswanthpur, Bengaluru, Karnataka 560022
Bangalore
KARNATAKA |
9606197707
sparshclinical@gmail.com |
| Dr Meghana Murthy |
Vagus Super Speciality Hospital |
Vagus Super Speciality Hospital
4th Main Rd, Malleshwaram, Bengaluru, Karnataka 560003
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madonna Hospital & Research Centre |
Approved |
| Institutional Ethics Committee Sai Sneh Hospital & Diagnostic Centre |
Approved |
| Institutional Ethics Committee-Sai Sneha Hospital & Diagnostic centre |
Approved |
| Madonna Hospital an Research Centre |
Approved |
| Sparsh Hospital Institutional Ethics Committee |
Approved |
| Vagus Institutional Ethics Committee |
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. Ayurveda Condition: Janapadoddhwansa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard of care treatment plus placebo |
Placebo Dose: 2400 mg/day (4 tablets of 300 mg placebo twice a day) for maximum 10 days along with standard of care treatment.
Route of administration: Orally with water
|
| Intervention |
Tadios along with standard of care treatment |
Test Product: TADIOS
Dose: 2400 mg/day (4 tablets of 300 mg active ingredient twice a day) for maximum 10 days along with standard of care treatment.
Route of administration: Orally with water
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female, aged between 18 to 65 years (both inclusive)
2. Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples.
3. Patients who are hospitalized into designated hospital for COVID 19 treatment
4. Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19
5. Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India.
a) Mild Illness: Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, and headache. The elderly may present with atypical symptoms. These patients do not have any signs of dehydration, sepsis or shortness of breath.
b) Moderate Illness: Patient with pneumonia and no signs of severe pneumonia (Chest X-ray will be performed to rule out pneumonia in the suspected subjects).
6. Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study
7. Those who can comply with the requirements and processes in the clinical study
8. Women of childbearing age must be negative to urine pregnancy test during screening
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe COVID-19
2. Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigator’s judgment
3. Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding
4. Patients with cardiovascular, liver, and kidney disease
5. Self-reported patients being a recipient of immunosuppressive therapy
6. Self-reported patients who are allergic to this dietary supplements
7. Patients taking a health functional food or medicine that may affect the body’s antioxidant, anti-inflammatory activity, and lungs within 6 weeks of the first visit
8. Patients who participated in another clinical trial within 1 month before screening
9. Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study
10. Patients consuming any herbal medicine
11. Self-reported patients with cases of surgical menopause (hysterectomy, oophorectomy of both ovaries) or sterilization procedures (tubal ligation or tubectomy of both fallopian tubes). Menopause refers to 1 year of no menstruation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Antioxidative and inflammatory biomarkers: TNF-α, CRP, IL-6, IL-1ra, Hb, and Ferritin
(2) Clinical measurements-
a) 8-point ordinal scale for clinical improvement
b) Time to clinical recovery in clinical symptom scale
c) Proportion of clinical improvement in clinical in symptom scale
(3) Quality of life
a) WHOQOL-WHO 5 wellbeing scale
b) Fatigueness assessment through fatigue severity scale
(4) Hospitalization
a) Duration of hospitalization
b) Time to discharge
|
Day 0, Day 10 or discharge or early termination, and Day 14.
clinical symptom scale daily till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Adverse event
(2) Hematological test, general chemical test, and urine test
(3) Vital signs
|
(1) Adverse events: Day 2, 4, 7 and 10/discharge/early termination
(2) Hematological test, general chemical test, and urine test: screening, Day 10/discharge/early termination and Day 14
(3) Vital signs: screening, Day 0, 2, 4, 7, 10/discharge/early termination and Day 14
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
100 patients diagnosed with COVID-19 by RT-PCR will be randomized in a ratio of 1:1 into TADIOS group and placebo group to evaluate efficacy and safety after intake over 10 days. |