Management of Acute Ischaemic Stroke with add-on homoeopathy
- Conditions
- Cerebral infarction,
- Registration Number
- CTRI/2023/09/057611
- Lead Sponsor
- Central Council for Research in Homoeopathy
- Brief Summary
REMARKS
The study site doesn’t have it’s own Ethical Committee at present. The Central Ethics Committee of Central Council for Research in Homoeopathy, which is within 50 km of the site has granted approval. The same has been uploaded.
STUDY SUMMARY
Title: Functional recovery assessment of persons with Acute Ischaemic stroke with homoeopathic intervention as an add-on to the standard treatment – A double blind randomised controlled trial
Short Title: Homoeopathic management of Acute Ischaemic stroke
Protocol No.: Version 3
Study Design: Double Blind Randomised Controlled Trial
Proposed Study Center: Janakpuri Super Speciality Hospital Society (JSSHS), an Autonomous Post-Graduate Institute. Ministry of Health & Family Welfare, Govt. of NCT of Delhi, Janakpuri, New Delhi
Protocol Details:
Approvals Received:
1. Scientific Advisory Board of CCRH
2. Central Ethics Committee (CCRH)
Protocol No.: 03
Protocol Team:
(i) Principal Investigator:
CCRH: Dr. Harleen Kaur, Research Officer (H)/Scientist- 2, CCRH
(ii) Co- Principal Investigator:
JSSHS: Dr. Vasundhara, Associate professor (Neurology), JSSHS
(iii) Study Mentors: Dr. Subhash Kaushik, Director General, CCRH,
(iv) Protocol Writing: Dr. Vasundhara, Dr. Harleen Kaur, Dr. Surbhi Jain,
Research Associate (H), Dr. Daisy Katarmal, Research Associate (H), CCRH
(v) Site investigators: Dr. Surbhi Jain, Research Associate (H)
Dr. xxx (to be appointed, Research Associate (Allopathy)
Objectives:
Primary Objective: To determine whether individualised homoeopathic treatment as an adjuvant to the standard treatment is better than the standard treatment alone for the functional recovery of Acute Ischaemic Stroke patients, as per change in validated Modified Rankin Scale (mRS), Stroke Impact Scale (SIS) version 3.0 questionnaire.
Secondary Objective: To determine whether individualised homoeopathic treatment as an adjuvant to the standard treatment is better than the standard treatment alone for the overall clinical improvement of Acute Ischaemic Stroke patients, as per Measure Yourself Medical Outcome Profile (MYMOP2) questionnaire.
Sample size 100 each arm; Total: 200
Inclusion Criteria:
1. Cases of any gender, more than 18 years of age, diagnosed with Acute Ischemic stroke [(ICD-11) 8B11: Cerebral ischaemic stroke] having symptoms for >6 hours to 7 days, on the basis of neurological clinical evaluation and neuro imaging.
2. Acute AIS patients with a history of AIS episode with 90% recovery of residual effects of previous episode.
3. Modified Rankin Scale (mRS) score from 2 to 5.
4. Written Informed consent from the patient. In participants with aphasia and dominant hand paralysis, consent will be taken from attendant. Witness consent/consent by hand gesture of the participant can be recorded Audio-Visually.
Exclusion Criteria:
1. Pregnant or lactating females.
2. Minor or rapidly improving stroke symptoms with complete recovery within 6 hours.
3. Cases of haemorrhagic stroke (subarachnoid haemorrhage, venous infarct), Transient Ischemic Attack (TIA).
4. Intraspinal surgery, serious head trauma (history or as a result of present episode of AIS).
5. Having previously diagnosed or clinically established disorders like recrudescence, migraine aura, seizures, peripheral vertigo and dizziness or Multiple sclerosis (MS) which may mimic AIS.
6. Neoplasia and other intracranial space-occupying lesions.
7. Severe, advanced cases of uncontrolled systemic diseases like cardiovascular, endocrinal, renal diseases, metabolic abnormalities like hyponatremia, hypocalcemia, hypoglycemia, uremia, or other disorders.
Study Product, dose, route:
Individualized Homoeopathic medicines in varied potencies in required doses shall be prescribed to be taken orally or by rubbing on skin or inhalation, along with the standard treatment in the adjuvant group. Each dose of indicated medicine shall consist of four globules (size no. 30) medicated with the dilution given orally and repeated as per the prescription, or 1 drop of the dilution will be given in 5ml (1 tsp.) of drinking water and repeated as per the prescription. The standard treatment regimen and identical placebo will be followed in the standard treatment group.
Study duration;
Duration of follow up is 2 years; (1 year for enrolment, 6 months for follow up and 6 months for data compilation) . Biweekly follow ups.
Statistical Methodology:
Data obtained during the study would be verified and analyzed using statistical methods adopted for comparative assessments on randomized patients, in discussion with statistical expert. Repeated measures ANOVA will be used.
Outcome measures:
Primary Outcome: Assessment of functional recovery through Modified Rankin Scale (at baseline, 3 months, 6 months) and individual domain scores of Stroke Impact Scale questionnaire (at baseline and monthly follow ups).
Secondary Outcome: Assessment of overall clinical improvement through Measure Yourself Medical Outcome Profile 2 (at biweekly follow up).
End point:
Subsequent episode of AIS within the follow up period of 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 200
- Cases of any gender, more than 18 years of age, diagnosed with Acute Ischemic stroke [(ICD-11) 8B11: Cerebral ischaemic stroke] having symptoms for >6 hours to 7 days, on the basis of neurological clinical evaluation and neuro imaging.
- Acute AIS patients with a history of AIS episode with 90% recovery of residual effects of previous episode.
- Modified Rankin Scale (mRS) score from 2 to 5.
- Written Informed consent from the patient.
- Pregnant or lactating females.
- Minor or rapidly improving stroke symptoms with complete recovery within 6 hours.
- Cases of haemorrhagic stroke (subarachnoid haemorrhage, venous infarct), Transient Ischemic Attack (TIA).
- Intraspinal surgery, serious head trauma (history or as a result of present episode of AIS).
- Having previously diagnosed or clinically established disorders like recrudescence, migraine aura, seizures, peripheral vertigo and dizziness or Multiple sclerosis (MS) which may mimic AIS.
- Neoplasia and other intracranial space-occupying lesions.
- Severe, advanced cases of uncontrolled systemic diseases like cardiovascular, endocrinal, renal diseases, metabolic abnormalities like hyponatremia, hypocalcemia, hypoglycemia, uremia, or other disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of functional recovery through Modified Rankin Scale (at baseline, 3 months, 6 months)and total & individual domain scores of Stroke Impact Scale questionnaire (at baseline & monthly follow ups) At baseline, 3 months, 6 months & monthly follow ups
- Secondary Outcome Measures
Name Time Method Assessment of overall clinical improvement through Measure Yourself Medical Outcome Profile 2 (MYMOP2) Biweekly follow up
Trial Locations
- Locations (1)
Janakpuri Super Speciality Hospital
🇮🇳West, DELHI, India
Janakpuri Super Speciality Hospital🇮🇳West, DELHI, IndiaDr Vasundhara AggarwalPrincipal investigator9958139095smile3108@gmail.com