Management of Acute Ischaemic Stroke with add-on homoeopathy
Scientific Title of Study
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
Trial Acronym
AIS-HOM
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Harleen Kaur
Designation
Research Officer (Homoeopathy)
Affiliation
Central Council for Research in Homoeopathy
Address
Room no. 313, Division - Clinical Research, Department of Clinical Research, CCRH Headquarters, 61-65, Institutional Area, Janakpuri, New Delhi
West DELHI 110058 India
Phone
9818709729
Fax
Email
dr.harleenkaur@gmail.com
Details of Contact Person Scientific Query
Name
Harleen Kaur
Designation
Research Officer (Homoeopathy)
Affiliation
Central Council for Research in Homoeopathy
Address
Room no. 313, Division - Clinical Research, Department of Clinical Research, CCRH Headquarters, 61-65, Institutional Area, Janakpuri, New Delhi
West DELHI 110058 India
Phone
9818709729
Fax
Email
dr.harleenkaur@gmail.com
Details of Contact Person Public Query
Name
Dr Vasundhara Aggarwal
Designation
Associate Professor (Neurology)
Affiliation
Janakpuri Super Speciality Hospital
Address
Department of Neurology, Division- Clinical Research, Room no. 304, C-2B, Lal Sai Mandir marg, Janakpuri, New Delhi
West DELHI 110058 India
Phone
9958139095
Fax
Email
smile3108@gmail.com
Source of Monetary or Material Support
Central Council for Research in Homoeopathy
Primary Sponsor
Name
Central Council for Research in Homoeopathy
Address
61-65, Institutional Area, Janakpuri, New Delhi-110058, India
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Vasundhara Aggarwal
Janakpuri Super Speciality Hospital
Department of Neurology, Division- Clinical Research, Room no. 304, C-2B, Lal Sai Mandir Marg, Janakpuri, New Delhi - 110058 (within 50 km of CCRH, from where Ethical Approval has been sought) West DELHI
The selection of medicines depends on individualisation of each case based on pathological and personal characteristics.
Dosage of the medicine will be decided as per the status of case by the Investigator. One dose will be 4 globules size 30 or 1 drop of the dilution in 5ml (1 tsp.) of drinking water.
Frequency- The medicine will be repeated depending on the potency and complaints of the patient in accordance with the principles of Homoeopathy. Once the improvement sets in, placebo is to be continued till the medicine continues to act.
Route- Oral or through inhalation or by rubbing on skin
Duration- 6 months
Comparator Agent
Placebo
The control group will receive identical placebo, each dose as 4 non- medicated sugar globules of size 30 or 1 drop of dispensing alcohol in 5ml (1 tsp.) of drinking water, along with standard care. Frequency- The medicine will be repeated depending on the potency and complaints of the patient in accordance with the principles of Homoeopathy. Route- Oral or through inhalation or by rubbing on skin. Duration- 6 months
Comparator Agent
Standard drugs used in Allopathy (Ecosprin, Atorvas, Clopidogrel,Calcium, Vitamin D3, Multiviatmin, Metformin, Amlodipine, Pantocid, Neurobion forte, Vildagliptin, Telma, Glimepiride, Monocef, Dulcoflex, etc.)
The dosage of standard drugs used in Acute Ischaemic Stroke will be decided as per IMP.
To be given orally or IV or through Ryles tube according to the condition of the patient.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
Assessment of overall clinical improvement through Measure Yourself Medical Outcome Profile 2 (MYMOP2)
Biweekly follow up
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/10/2023
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.
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.