Management of Post Covid through Siddha system of medicine

A single centre black box design randomised parallel group clinical trial to compare the efficacy of Siddha Post COVID package -1 (SIPCOP-1) and Siddha Post COVID package -2 (SIPCOP-2) in the functional status of COVID-19 recovered population, 2021, Tamil Nadu - SIPCOP 1 Vs SIPCOP 2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048340

Enrollment

236

Registered

2022-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z228- Carrier of other infectious diseases Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 3: B338- Other specified viral diseases

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.The individuals attending the Post COVID Management Centre, R&D wing, DIM&H, and have tested positive for COVID-19 through RT-PCR between 1 month to 3 months. 2.The patients who had tested RTPCR positive in the last 30 days and up to 90 days will be included in the trial. 3.Individuals who are free from clinical symptoms of Covid-19 infection (acute illness with or without fever - body temperature more than 100-degree Fahrenheit) for at least a week after the course of the disease will be included. 4.Irrespective of the severity of the disease all covid 19 infected and recovered individuals are included in the trial. 5.Patients who present with at least any 5 of the following symptoms of post covid---- brain fog, dizziness, loss of attention, confusion---, general fatigue, dyspnoea, cough, throat pain----- respiratory post-COVID, myalgias, arthralgias---- musculoskeletal post-COVID, post-traumatic stress disorder, anxiety, depression, insomnia---- psychological-related post-COVID, ageusia, anosmia, parosmia, skin rashes---- other manifestations will be included in the trial. 6.Age: 18 years and above.

Exclusion criteria

Exclusion criteria: 1.History of diabetes mellitus, hypertension, cardiac ailments and immune-compromised individuals are excluded from the trial. 2.Patients with autonomic post-COVID (chest pain, tachycardia, palpitations), gastrointestinal post-COVID (diarrhoea, abdominal pain, vomiting) will not be included in the trial.

Design outcomes

Primary

Measure	Time frame
Improvement in functional status of the participants by the reduction in score of post-COVID-19 Functional Status (PCFS) scale Reduction of dyspnoea assessed using mMRC dyspnea scale Reduction of depression, anxiety and stress assessed using DASS-21 scale Reduction of fatigue assessed by fatigue assessment scale. Perceived exertion will be assessed using the Borg scale Muscle strength will be assessed using MMT scale Timepoint: Baseline and on 46th day	—

Measure

Time frame

Improvement in functional status of the participants by the reduction in score of post-COVID-19 Functional Status (PCFS) scale Reduction of dyspnoea assessed using mMRC dyspnea scale Reduction of depression, anxiety and stress assessed using DASS-21 scale Reduction of fatigue assessed by fatigue assessment scale. Perceived exertion will be assessed using the Borg scale Muscle strength will be assessed using MMT scale Timepoint: Baseline and on 46th day

—

Secondary

Measure	Time frame
Safety of the interventional drug package SIPCOP 1 and SIPCOP 2 will be ascertained by laboratory investigation and reporting of adverse events. Timepoint: Baseline and on 46th day	—

Countries

India

Contacts

Public ContactDr P Elankani

Siddha Central Research Institute

crisiddha@gmail.com9566268262

Outcome results