- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05715554
Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients
February 6, 2023 updated by: Innowage Limited
Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients: Results of a Pilot, Pragmatic, Randomized, Open Label, Controlled Trial Investigating Acceptability and Feasibility
A growing number of studies identify a spectrum of persistent symptoms experienced by COVID-19 patients for months after recovery.
Symptoms include cough, fatigue, dyspnea, pain, and brain fog (cognitive impairment, including confusion and memory loss), which have a negative impact on daily activities.
Homoeopathic practitioners from around the world have documented a number of successful cases of Post COVID treatment.
Even though evidence from practice-based research is limited, the purpose of the current study was to evaluate the effect of individualized homoeopathy treatment on post-COVID syndrome.
Study Overview
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajasthan
-
Dausa, Rajasthan, India
- Gyansanjeevani India
-
Jaipur, Rajasthan, India
- Gyansanjeevani India
-
Mandawa, Rajasthan, India
- Gyansanjeevani India
-
Sawai Madhopur, Rajasthan, India
- Gyansanjeevani India
-
Sīkar, Rajasthan, India
- Gyansanjeevani India
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed COVID-19 history
- Persistent respiratory symptoms for more than three months after COVID-19
- Able to provide informed consent
Exclusion Criteria:
- Presence of respiratory issues without COVID-19 diagnosis
- On complementary and Alternative Treatment
- Symptoms of infection
- Pregnancy or Breastfeeding
- Cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Homeopathy Group
Individualized Homeopathy Treatment provided by homeopathic physicians
|
Individualized homoeopathic medicines on impregnated lactose pellets was prescribed based on totality of physical, emotional, and mental symptoms.
|
NO_INTERVENTION: Standard Group
Usual care provided by primary care physicians were followed by patients in the standard group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough severity
Time Frame: 8 weeks
|
Severity from 0-10 visual analog scale, where 0 is none to 10 is most severe.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dyspnea
Time Frame: 8 weeks
|
Change in dyspnea using Modified Borg Scale (0 is best to 10 is wore)
|
8 weeks
|
Change in Fatigue
Time Frame: 8 weeks
|
Change in fatigue severity scale (0 -7 no fatigue to worse )
|
8 weeks
|
change in Quality of Life
Time Frame: 8 weeks
|
Saint George Respiratory Questionnaire (SGRQ)to assess the quality of life (scores ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sadhana Sharma, Gyansanjeevani India
- Study Director: Vesna Marinković, Collaborative Homeopathy Research Network
- Study Chair: Neha Sharma, Innowage Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 6, 2022
Primary Completion (ACTUAL)
December 18, 2022
Study Completion (ACTUAL)
January 12, 2023
Study Registration Dates
First Submitted
February 6, 2023
First Submitted That Met QC Criteria
February 6, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-G-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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