Treatment of Acute Stroke With Cromolyn(Single Dose)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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Mastocytes were proven to have a central rule in their development of the lipoid plaque of the vascular system. Mastocytes also has an important role in the stabilisation of the plaque in the building of the brain barrier. Different animal studies show that the inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic stroke.It was also shown that post stroke inflammation process was also blocked by the inhibition of mastocytes.Other studies showed up to 100% decrease in the brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors.

Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used in the previously mentioned studies.

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Detailed Description

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Conditions

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Acute Stroke

Study Design

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Intervention Model

PARALLEL

Study Groups

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sugar pill

sugar pill dissolved in water to be given 4 times a day 30 minutes prior to meals

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type DRUG

sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals

Cromolyn

Cromolyn dose of 200mg(dissolved in water) will be given 4 times a day(30 minutes before a meal)

Group Type ACTIVE_COMPARATOR

CROMOLYN

Intervention Type DRUG

Cromolyn 200mg (dissolved in water) given 4 times a day

Interventions

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CROMOLYN

Cromolyn 200mg (dissolved in water) given 4 times a day

Intervention Type DRUG

sugar pill

sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals

Intervention Type DRUG

Other Intervention Names

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NASALCROM GASTROCOM

Eligibility Criteria

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Inclusion Criteria

1. Infarction of the anterior Circulation system.
2. Both genders
3. Age \> 20 years
4. NIHSS \> 5 -

Exclusion Criteria

1. Non- ischaemic stroke
2. Additional disease of the CNS
3. Known allergy to cromolyn
4. Diseae of mastocytosis
5. Renal or Hepatic failure (acute or chronic)
6. Inability to sign consent form (dementia or sensory aphasia)
7. Lacunar infarctions
8. INfarction present in cerebellum or brain stem -

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No