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The Universal Trial Number (UTN) is U1111-1262-7419
The Universal Trial Number (UTN) is U1111-1262-7419
Protocol summary
Study aim
To find the effectiveness of integrative treatment of COVID-19 patients.
Design
Interventional study design. phase 1 clinical trials
Settings and conduct
Knowledge Research and Innovation Center, Pakistan (KRIC)
Online consultation and online questionnaire filled by the participants.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
a. Both genders
b. Aged between 18-80 years
c. Mild, moderate or severe infection.
d. COVID-19 positive on the basis of symptoms, physical test and lab test.
Exclusion Criteria
a. Any tumor or malignancy
b. Recent surgery
c. Patient on invasive / non-invasive ventilator (critical)
d. Taking any other medicine parallel to PAK-20 and Oniater for treatment of COVID-19.
e. Taking any immunosuppressant
The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Clinical Trial Based Evaluation
Public title
COVID-19 Cure Using Integrative Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders
Aged between 18-80 years
Mild, moderate or severe infection
COVID-19 positive on the basis of symptoms, physical test and lab test
Exclusion criteria:
Any tumor or malignancy
Recent surgery
Patient on invasive / non-invasive ventilator (critical)
Taking any other medicine parallel to PAK-20 and Oniater for treatment of COVID-19.
Taking any immunosuppressant
Age
From 18 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
39
Actual sample size reached:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Research Committee of Knowledge Research and Innovation Center, Pakistan (KRIC)
SARS-associated coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Fever
Timepoint
Before intervention and (1,3,5) odd days after intervention
Method of measurement
Thermometer
2
Description
Cough
Timepoint
Before intervention and (1,3,5,7,9,11) odd days after intervention
Method of measurement
Cough Scale
3
Description
Sore Throat
Timepoint
Before intervention and (1,3,5,7,9,11) odd days after intervention
Method of measurement
Sore Throat Scale
4
Description
Shortness of Breath
Timepoint
Before intervention and (1,3,5,7,9,11) odd days after intervention
Method of measurement
Borg Scale of Short of Breath
5
Description
Muscle Pain
Timepoint
Before intervention and (1,3,5,7,9,11) odd days after intervention
Method of measurement
Numeric pain rating Scale
Secondary outcomes
1
Description
PCR-RT for COVID-19
Timepoint
Before intervention and 14th day after intervention
Method of measurement
PCR-RT Lab test
2
Description
Chest X-ray
Timepoint
Before intervention and on 14th day after intervention
Method of measurement
Radiological X-ray findings
3
Description
10 Second Breath Hold Test
Timepoint
Before intervention and on 14th day after intervention
Method of measurement
Physical 10 Second breath Hold
Intervention groups
1
Description
Intervention group: Methods: Participants 34 COVID-19 patients with mild to severe symptoms both males and females were selected. Outcomes: Primary Outcomes measuring: symptoms’ intensity; Fever was measured on thermometer scale, the intensity of Cough was measured on Visual Analogue Scale (VAS) , Shortness of Breath was observed on Borg dyspnea scale, Muscle Pain was measured on VAS Scale and Throat Soreness was measure on sore throat scale. Secondary Outcomes effectiveness of the treatment; measuring significance of mean difference of symptoms’ intensity, from day one till day of recovery to a maximum of 12 days. Tertiary Outcomes patient’s satisfaction of the treatment was measured on 5-point Likert scale. Study Setting: Knowledge Research and Innovation Center, Lahore Pakistan. Inclusion Criteria: a. Both genders b. Aged between 18-80 years c. Mild, moderate or severe infection. d. COVID-19 positive on the basis of symptoms, physical test and lab test. Exclusion Criteria a. Any tumor or malignancy b. Recent surgery c. Patient on invasive / non-invasive ventilator (critical) d. Taking any other medicine parallel to PAK-20 and Oniater for treatment of COVID-19.Taking any immunosuppressant. Interventions Experimental group was given 1gm of PAK-20 (containing Cloves, Black pepper, Cumin Seed, Cinnamon, Black cardamom, Mace Spice, Nutmeg, Star anise and Bay leaves) in 250ml of Combo 1 (soup/meat stock) twice a day for a maximum of 12 days, 50 ml of Oniater (onion water) once a day for consecutive 3 days and 250ml of Combo 2 (herbal tea) containing cloves, black pepper, green cardamom, black cardamom, stick of cinnamon, ginger slice, fennel seeds and half lemon juice twice a day for a maximum of 12 days. Datseed containing date filled with black seeds (kalonji) was given once a day for a maximum of 12 days. Ajwa dates seed powder (market available herbal compound) was given to specifically those patients who were already suffering from diabetes, cardiovascular disease or hyperlipidemia. Use of fruits; like Apples, Mangoes, pure organic juices; like carrot juice, orange juice, apple juice, mango milk shake even beyond 12 days until strength was restored. Meat/ lentils use for intake of proteins till recovery. Use of 70gm of Talbina once per day that increases 94 kcal, served as powerful energy diet.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Knowledge Research and Innovation Center, Pakistan (KRIC)