Integrated Homoeopathy and WHO rehabilitation care for long COVID

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Indicated homoeopathic medicines and WHO Rehabilitation Self‐Management after COVID‐19 : Homoeopathic drugs as detailed in the standard Homoeopathic Materia Medica and in the Homoeopathic Pharmacopoeia (India/US) will be used in the study based on symptom similarity (Homoeopathic principle). The drugs identified for the trial shall be procured from a GMP compliant pharmaceutical firm approved by the Council. Medicines will be dispensed in sugar globules of standard size 30. Dose: Homoeopathic Medicine shall be given in 30c, 200c or 1M potency as per the prescribing totality of the case. Each dose of the selected medicine will be 4 pills of size 30. Route of Administration: The medicine would be taken orally. Duration: Indicated homoeopathic medicines will be prescribed as per the principles of Homoeopathy for 6 month. Control Intervention1: Placebo and WHO Rehabilitation Self‐Management after COVID‐19 : Identical placebo shall be given, an unmedicated plain white pills along with the WHO Rehabilitation Self‐Management. Dose : Three times a day and each dose will be 4 pills of size 30. Route of Administration: The Placebo would be taken orally. Duration: 6 month. CONDITION: Health Condition 1: U071‐ COVID 19 virus identified PRIMARY OUTCOME: Change in symptom severity or clinical recovery of Long COVID complaintsTimepoint: At baseline, monthly follow‐up up to 6 months ; SECONDARY OUTCOME: Change in functional status assessed using PCFS. ; 6‐minute walk test (the distance acquired during si Xminutes walking) quantifying the physical performance, any dyspnoea and endurance. ; Changes in fatigue: Chalder Fatigue Scale (CFQ‐11) scale ; Changes in anxiety: Hamilton Anxiety Rating Scale (HAM‐A) ; Changes in health‐related quality of life: 12‐item Short Form Survey (SF12) ; Change in numeric rating scale (NRS) for all other complaints ; Timepoint: At baseline, and up to 6 months INCLUSION CRITERIA: History of confirmed COVID‐19 infection in last 6 months; Minimum 4 weeks after the confirmed COVID‐19 report. Residual or any other clinical complaints reported to be occurring after COVID‐19 like fatigue, fever (unknown reason), anxiety, joint pain, breathlessness, headache, or any other non‐serious clinical illness not explained by an alternative diagnosis. Cases who have recovered clinically&/or laboratory confirmed negative. Patients agreeing to perform WHO self‐care rehabilitation program under guidance of the physician. Patients willing to participate in the study and give written informed consent
Epistemonikos ID: facf1a15ece640f7bbdb348249b18037ea2cba30
First added on: Oct 02, 2023