Research on NeuroAid™

NeuroAid10™ is derived from NeuroAid™. NeuroAid10™ is a dietary supplement which contains the same major ingredients as NeuroAid™ to the exception of secondary natural abstracts from animal origin. These have been removed to comply with FDA guidelines on dietary supplement for the United States market and to support local availability in the USA.

Research conducted in China proved NeuroAid™ existing efficiency and safety data. The clinical studies conducted in China, were double-blind controlled clinical trials where NeuroAid™ efficacy was assessed.

606 ischemic stroke patients at a late rehabilitation stage (2 weeks - 6 months) were recruited in double-blind randomized studies: 201 patients for the first study and 405 patients for the second one.

Efficacy was assessed after one month of treatment. As per most of the Western stroke trials, they consisted of measuring functional outcomes and neurological deficit with standard scales.

During Clinical studies, stroke patients have undergone several physical check-up such as blood, hepatic, cardiac or renal standard testing to assess the safety of NeuroAid™. No abnormal changes were observed.

1) Efficacy

Functional Outcome

Functional outcome defines the level of independence of the patient after a stroke and during the recovery. As such the scales commonly used by the doctors to assess the level used are modified Rankin scale (mRS) or the Barthel Index to assess the patient’s independence to do the daily activities.

Clinical trial on NeuroAid™ on 605 patients showed that patient on NeuroAid™ had 2.11 times more chance to reach independence. The below plot shows that patients on NeuroAid™ had a significantly better chance of leading an independent life than those of the control group*.

* Not receiving NeuroAid™

Neurological Deficit Research

1. Upper Limb Paralysis

Limb paralysis is the most common symptom post stroke.  The side of the body affected is opposite to the part of the brain affected by stroke. The functions affected can be loss of gross or fine motor functions.  There is an associated loss of sensory impairment, which can cause the patient to suffer from pain, burning, sensation of nombness. The patient might not become aware of as he does not feel the pain. The other symptoms can be numbness or tingling.

Here below are the results of these clinical trials enrolling 605 patients, 400 receiving NeuroAid™ and 205 a control medicine:

The upper limb motor improvement was significant for patients receiving NeuroAid™. The results are statistically significant (p=0.006)

The plot on finger paralysis (Fig.2) improvement also shows it to be slightly favorable to NeuroAid™. The first study was clearly positive, although the second one neutral to slightly positive, the overall being not statistically significant.

2. Lower Limb Paralysis

The lower limb motor improvement was significant for patients receiving NeuroAid™. The results are indeed statistically significant (p=0.0001)

The above figure 1 and 2 shows that NeuroAid™ significantly helps in improving lower limb paralysis as well as toe paralysis respectively in post stroke patients. These results are statistically significant (p=0.02).

3. Facial Paralysis

A number of patients have facial paralysis following their stroke, which could be due to the involvement of the facial nerve itself (complete paralysis) or the motor area of the brain supplied by the nerve (partial paralysis). A few of the signs and symptoms of the patients suffering from facial paralysis are:

• asymmetrical smile, tearing or dry eye, inability to close eye, abnormal blink, inability to whistle or pucker lips,
• buccinator paralysis (food caught in cheek of paralyzed side), inability to "puff" one's cheeks, drooling of liquids from corner of paralyzed mouth,
• hyperacussis (perceiving sounds as unduly loud),excessive perspiration, weakened facial musculature,
• lack of wrinkling on forehead of paralyzed side, change in taste (sensory part of the nerve involved), changes in speech, tightness / swelling of facial muscle.
  

The plot below details the results of the clinical trial on 605 patients. The first study was clearly positive on the effect of NeuroAid™ on facial paralysis, the 2nd study slightly positive but not statistically significant. On average, NeuroAid™ seems to help victims of facial paralysis.

4. Speech Problems and Motor Function

A person who has suffered a cerebral vascular accident or CVA (commonly known as a stroke) may experience the following speech problems-
Aphasia is a condition that can affect all language areas including speaking, understanding, reading, and writing in varying degrees

The following suggestions may be helpful: Ask questions that call for a yes or no answer, Speak in short phrases, Talk about familiar topics or people, Give the person time to think of words.

Apraxia is a motor planning problem which affects the ability to formulate the sounds of speech.

The following suggestions may be helpful in: Ask the person to slow down and say each word carefully, avoid interrupting the person, encourage the use of gestures, encourage any vocalization such as singing familiar songs.

Dysarthria is a weakness or paralysis of the muscles used for speech and results in a person's speech being slurred and difficult to understand.

The following suggestions may be helpful: Ask the person to speak slowly and overemphasize the words, encourage the person to open his mouth, Let the person know when you don't understand and ask him to repeat.

The above plot shows the outcome of NeuroAid™ for patients in totality when we look at the overall improvement in motor functions of upper and lower limb as well as speech; NeuroAid™ is slightly more favorable than control. The first study was clearly positive on the effect of NeuroAid™, the 2nd study slightly positive. The overall results are not statistically significant

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2) Safety

During Clinical studies, stroke patients have undergone several physical check-up to assess the safety of NeuroAid™ such as blood, hepatic, cardiac or renal standard testing. No abnormal changes were observed.

In 2005-06, three additional safety trials were implemented on DPJ. The conclusion of these studies is that DPG can safely be administrated without modification of hematological and bio-chemical parameters.

Below is an abstract of the scientific paper written after completion of studies, this paper is currently undergoing peer-review process for publication.

Background and Objective: Previous studies on Danqi Piantan Jiaonang (DPJ, NeuroAid™), a traditional Chinese medicine, in stroke patients showed promising results. Our aim was to determine the safety of DPJ in normal subjects and stroke patients through a series of studies assessing its immediate and long-term effects, alone and in combination with aspirin, on hematological, hemostatic, and biochemical parameters.

Methods: We conducted three studies from December 2004 to May 2006. Study I was a case series which recruited 32 healthy volunteers who were given two oral doses of four DPJ capsules (0.4g/ capsule) six hours apart. Study II was a randomized controlled trial of 22 healthy volunteers to receive either one oral dose of aspirin 300 mg alone or a combination of one dose of aspirin 300 mg and two doses of four DPJ capsules taken six hours apart. For both studies I and II, hemostatic parameters (PT, aPTT, Fibrinogen, platelet aggregation, D-Dimer) were tested at baseline, 2 hours, and 8 hours. Study III was a case series which recruited 10 patients with recent ischemic stroke (within 7 days) who were given four DPJ capsules taken orally three times a day for one month. Blood tests for hemostatic, hematological (complete blood count), and biochemical parameters (glucose, creatinine, ALT, AST, C-reative protein) were performed at baseline, 1 week, and 4 weeks.

Results: Apart from the expected changes in platelet aggregation in subjects taking aspirin, no significant differences were detected in hemostatic parameters at baseline, 2 hours, and 8 hours after oral intake of DPJ alone or in combination with aspirin. Likewise, no significant differences were observed in hematological, hemostatic, and biochemical parameters at baseline, 1 week, and 4 weeks of oral intake of DPJ.

Conclusion: Danqi Piantan Jiaonang (NeuroAid™) does not significantly modify hematological, hemostatic, and biochemical parameters in normal subjects and stroke patients.

In September 2007, TIERS trial has kicked off. TIERS is a pilot study aimed at understanding the detailed components of neurological rehabilitation triggered by DPJ. TIERS is a double blind randomized placebo-controlled trial, recruiting initially 40 patients in the first month after their stroke. TIERS is implemented at Tam Tock Seng Hospital (Singapore)

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3) CHIMES TRIAL (now recruiting in Asia) : NeuroAid™ at the acute phase of Stroke

The objective of the trial is to test the hypothesis that NeuroAid™ is superior to Placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction with intermediate range of severity (6< NIHSS< stroke the of hours 48 within recruited>

This is a multi-center double blind controlled randomized trial comparing NeuroAid™ versus a matched placebo assessing efficacy after three months of treatment.

The Study Endpoints are:

• Primary Efficacy Outcomes is the modified Rankin Scale grades at 3 months for all randomized subjects.
• Secondary Efficacy Outcomes are standard Western scales such as for stroke: NIHSS, mRS, Barthel index, mini-mental State Examination (MMSE).

Eligibility criteria have been chosen to allow most of the ischemic stroke patients to be included in the study and benefit from the TCM treatment.

As per standard clinical trial guidelines, the Chimes Society has appointed a Data and Safety Monitoring Board that will provide an unbiased process through which the Chimes study will be monitored and patient safety protected.

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Inclusion criteria

A subject will be eligible for inclusion in the trial only if all the following criteria apply at Baseline:

• Cerebral infarction of moderate severity
• Beginning of treatment within 48 hours after symptoms onset
• 18 years old and above
• No existing disability pre-stroke (mRS<1)
• Non childbearing potential for females

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Exclusion criteria

A subject will not be eligible for inclusion in the trial if any of the following criteria apply at baseline:

• Evidence of an other diagnosis (hemorrhage...)
• Patient benefiting from thrombolysis
• Known contra-indication for the use of all antiplatelet drugs
• Patient on anticoagulation therapy
• Co-existing systemic diseases (terminal cancer, renal failure cirrhosis, severe dementia or psychosis)
• Recent participation in another clinical trial within the last three months

For information on clinical trials please download the NeuroAid™ clinical pack and please visit the CHIMES Society website at www.chimes-society.org