Post-COVID SyndromeNCT05715554
Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients
A study testing Homeopathy in people with Post-COVID Syndrome, run by Innowage Limited at 5 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-COVID Syndrome
- What is being tested?
- Homeopathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 5 sitesIndia
- Study dates
- 6 Aug 2022to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COVID-19 history
- Persistent respiratory symptoms for more than three months after COVID-19
- Able to provide informed consent
Who cannot join
- Presence of respiratory issues without COVID-19 diagnosis
- On complementary and Alternative Treatment
- Symptoms of infection
- Pregnancy or Breastfeeding
- Cognitive impairment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Gyansanjeevani India
Dausa, Rajasthan
Gyansanjeevani India
Jaipur, Rajasthan
Gyansanjeevani India
Mandāwa, Rajasthan
Gyansanjeevani India
Sawai Madhopur, Rajasthan
Gyansanjeevani India
Sīkar, Rajasthan
About this study
Official title: 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.
- Conditions
- Post-COVID Syndrome
- Being tested
- Homeopathy
- Keywords
- Rehabilitation, Homeopathy, Post-COVID Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeopathyOther
Individualized homoeopathic medicines on impregnated lactose pellets was prescribed based on totality of physical, emotional, and mental symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Homeopathy Group | Experimental | Individualized Homeopathy Treatment provided by homeopathic physicians Receives: Other: Homeopathy |
| Standard Group | No intervention | Usual care provided by primary care physicians were followed by patients in the standard group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough severity
Severity from 0-10 visual analog scale, where 0 is none to 10 is most severe.
Measured: 8 weeks
Secondary outcomes (3)
Change in dyspnea
Change in dyspnea using Modified Borg Scale (0 is best to 10 is wore)
Measured: 8 weeks
Change in Fatigue
Change in fatigue severity scale (0 -7 no fatigue to worse )
Measured: 8 weeks
change in Quality of Life
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Aug 2022
- Primary completion18 Dec 2022
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innowage Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gyansanjeevani India, Collaborative Homeopathy Research Network
- Responsible party
- Sponsor
- Investigators
- Sadhana Sharma, Principal investigator, Gyansanjeevani IndiaVesna Marinković, Study director, Collaborative Homeopathy Research NetworkNeha Sharma, Study chair, Innowage Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715554
- Sponsor's protocol ID
- I-G-001
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients: Results of a Pilot, Pragmatic, Randomized, Open Label, Controlled Trial Investigating Acceptability and Feasibility
- ClinicalTrials.gov ID
- NCT05715554
- Acronym / sponsor ID
- I-G-001
- Conditions
- Post-COVID Syndrome
- Keywords
- Rehabilitation, Homeopathy, Post-COVID Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Innowage LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Gyansanjeevani India, Collaborative Homeopathy Research Network
- Study start
- 6 Aug 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathy Group | Experimental | Other: HomeopathyIndividualized Homeopathy Treatment provided by homeopathic physicians |
| Standard Group | No intervention | –Usual care provided by primary care physicians were followed by patients in the standard group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed COVID-19 history
- Persistent respiratory symptoms for more than three months after COVID-19
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Presence of respiratory issues without COVID-19 diagnosis
- On complementary and Alternative Treatment
- Symptoms of infection
- Pregnancy or Breastfeeding
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomeopathyIndividualized homoeopathic medicines on impregnated lactose pellets was prescribed based on totality of physical, emotional, and mental symptoms. | Other | Homeopathy Group |
Primary outcome
Cough severity
Time frame: 8 weeks
Severity from 0-10 visual analog scale, where 0 is none to 10 is most severe.
3 secondary outcomes
Change in dyspnea
Time frame: 8 weeks
Change in Fatigue
Time frame: 8 weeks
change in Quality of Life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Related trials for Post-COVID Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadhana Sharma principal investigator
Gyansanjeevani India
Vesna Marinković study director
Collaborative Homeopathy Research Network
Neha Sharma study chair
Innowage Limited
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeopathy in people with Post-COVID Syndrome, run by Innowage Limited at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough severity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.