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Protocol summary
Knowledge Research and Innovation Center, Pakistan (KRIC)
Online consultation and online questionnaire pre and post treatment was filled by the patients.
Knowledge Research and Innovation Center, Pakistan (KRIC)
questionnaire pre and post treatment was filled by the patients.
Knowledge Research and Innovation Center, Pakistan (KRIC) Online consultation and online questionnaire pre and post treatment was filled by the patients.
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
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, Oniater and Hing for treatment of COVID-19.
e. Taking any immunosuppressant
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, Oniater and OniaterHing for treatment of COVID-19. e. Taking any immunosuppressant
Single intervention group.
Methods: 34 COVID-19 patients with mild to severe symptoms both males and females were selected who will be willing to undergo the Intervention of Prophetic Medicine. Intervention group was given 1gm of PAK-20 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) 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. 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.
Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet.
Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms both males and females were selected who will be willing to undergogiven the Intervention of Prophetic Medicine. Intervention group was givenBaseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a maximummax of 12 days, 50 ml of Oniater (onion water) once a day for consecutive 3 days and 250ml of. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of 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. Use of fruits; like Applesprotein heavy diets, Mangoesfruits, pure organic juices; like carrot juice, orange juice, apple juice, mango milk shakeshakes and fresh juices given 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, which served as powerfulhigh potency oral multivitamins energy diet.
General information
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Minor change in Sub Title and few rearrangements of sentences
Minor change in Sub Title and few rearrangements of sentences
The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Clinical Trial Based Evaluation
The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Single Group, Pretest-Posttest clinical Trial
The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A ClinicalSingle Group, Pretest-Posttest clinical Trial Based Evaluation
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
Any tumor or malignancy
Recent surgery
Patient on invasive / non-invasive ventilator (critical)
Taking any other medicine parallel to PAK-20, Oniater and Hing for treatment of COVID-19.
Taking any immunosuppressant
Any tumor or malignancy Recent surgery Patient on invasive / non-invasive ventilator (critical) Taking any other medicine parallel to PAK-20, Oniater and OniaterHing for treatment of COVID-19. Taking any immunosuppressant
Intervention groups
#1
Single intervention group. Methods: 34 COVID-19 patients with mild to severe symptoms both males and females were selected who will be willing to undergo the Intervention of Prophetic Medicine. Intervention group was given 1gm of PAK-20 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) 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. 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.
Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet.
Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms both males and females were selected who will be willing to undergogiven the Intervention of Prophetic Medicine. Intervention group was givenBaseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a maximummax of 12 days, 50 ml of Oniater (onion water) once a day for consecutive 3 days and 250ml of. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of 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. Use of fruits; like Applesprotein heavy diets, Mangoesfruits, pure organic juices; like carrot juice, orange juice, apple juice, mango milk shakeshakes and fresh juices given 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, which served as powerfulhigh potency oral multivitamins energy diet.
Protocol summary
Study aim
To find the effectiveness of integrative treatment of COVID-19 patients.
Design
Interventional study design. sample size 34, non-randomized single group pre post . phase 1 clinical trials
Settings and conduct
Knowledge Research and Innovation Center, Pakistan (KRIC)
questionnaire pre and post treatment was filled by the patients.
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, Oniater and Hing for treatment of COVID-19.
e. Taking any immunosuppressant
Intervention groups
Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet.
Minor change in Sub Title and few rearrangements of sentences
Acronym
COVID-19
IRCT registration information
IRCT registration number:IRCT20200823048495N1
Registration date:2020-12-12, 1399/09/22
Registration timing:retrospective
Last update:2021-03-21, 1400/01/01
Update count:3
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Umber Nawaz
Name of organization / entity
Knowledge Research and Innovation Center
Country
Pakistan
Phone
+92 42 35440889
Email address
umber@kric.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-17, 1398/10/27
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
2020-03-17, 1398/12/27
Actual recruitment end date
2020-07-01, 1399/04/11
Trial completion date
2020-07-01, 1399/04/11
Scientific title
The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Single Group, Pretest-Posttest clinical Trial
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, Oniater and Hing 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
1
Registry name
World Health Organization Universal Trial Number
Secondary trial Id
U1111-1262-7419
Registration date
2020-12-15, 1399/09/25
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
Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Knowledge Research and Innovation Center, Pakistan (KRIC)