Regencell Bioscience’s Standardized Formulae Are Shown to Reduce ADHD and ASD Symptoms in the Interim Results of its Second Efficacy Trial
- The Sik-Kee Au TCM Brain Theory® Assessment for ADHD and ASD (“SKATBT-A3”), which measures the effectiveness of the treatment on the patient’s overall body and neurodevelopmental conditions, showed a mean percentage improvement of 37% in the second efficacy trial based on the scoring system of SKATBT-A3.
- The first efficacy trial using personalized TCM formulae have shown a mean percentage improvement of 30% in ADHD symptoms and a mean percentage improvement of 37% in ASD symptoms, based on the scoring systems under the Vanderbilt ADHD Diagnostic Parent Rating Scale (“VADRS”) and the Autism Treatment Evaluation Checklist (“ATEC”), respectively, after 3 months of treatment.
- The ongoing second efficacy trial using standardized TCM formulae have shown a mean percentage improvement of 21% in ADHD symptoms and a mean percentage improvement of 22% in ASD symptoms, based on the scoring systems under VADRS and ATEC respectively, after 3 months of treatment.
September 12, 2022 09:15 AM Eastern Daylight Time
HONG KONG--(BUSINESS WIRE)--Regencell Bioscience Holdings Limited (Nasdaq: RGC) (“Regencell”) today announced its interim results from its second efficacy trial.
Common improvements include better sleep quality, reduced temper, better bowel movement and healthier complexion
Regencell conducted its second efficacy trial using standardized Traditional Chinese Medicine (“TCM”) formulae. “Our aim is to save and improve lives by making our standardized TCM formulae widely available to ADHD and ASD patients around the world. It is known that there is a significant economic impact and increased parental burden to families that care for children with ADHD and ASD. These positive data from the second efficacy trial bring us one step closer to improving the conditions and quality of life of patients and reducing the negative impact that ADHD and ASD have on patients and their families,” said Yat-Gai Au, founder and CEO of Regencell.
Second Efficacy Trial
The primary objective of the second efficacy trial is to evaluate and assess the effectiveness of Regencell’s standardized TCM formulae in reducing ADHD and ASD symptoms through a holistic approach during the course of a 3-month treatment.
The second efficacy trial is a non-blinded efficacy trial. Regencell started its recruitment program in August 2021 through direct invitations to members of a non-governmental organization that serves the ADHD and ASD community. Parents and guardians of children with ADHD and ASD were invited to apply for the program.
Patients between the ages of 6 and 12 at the time of the treatment and who were clinically diagnosed with ADHD and/or ASD were eligible to participate in the program. The program required all recruited patients to stop all their existing medications, attend weekly treatment sessions with their parents, and follow the TCM Practitioner’s dietary guidelines, during the 3-month treatment. After a rigorous screening process, Regencell selected 7 children (6 males and 1 female) to participate in the trial. 3 of the patients were diagnosed with ADHD and 4 of them with ASD. All participants resided in Hong Kong.
To measure the improvement of the children’s symptoms after taking the TCM Formulae in the trial, Regencell used
SKATBT-A3, an assessment developed by Regencell based on patients’ overall body and neurodevelopmental conditions;
VADRS, an ADHD assessment; and
ATEC, an ASD assessment.
SKATBT-A3 is a 48-item questionnaire designed and developed by Regencell to evaluate the effectiveness of a treatment in improving ADHD and ASD patients’ symptoms. SKATBT-A3 assesses a patient’s overall physical and neurodevelopmental conditions. SKATBT-A3 includes elements that are conditions of patients usually observed during TCM treatments such as: (i) speech/language/communication; (ii) patients’ sociability; (iii) sensory/cognitive awareness; and (iv) physical health and behavior.
For example, SKATBT-A3 examines:
the flexibility of the child’s tongue (e.g., prior to treatment, the child may be unable to extend his tongue and had to use his own fingers to pull and stretch his tongue);
the child’s willingness and proactiveness to participate in social gatherings and to learn (e.g., the child’s ability to focus and engage in school work); and
involuntary twitching.
The effectiveness of a treatment is demonstrated through the child’s post-treatment tongue control and flexibility, the ability to focus for a longer period of time and less frequent involuntary twitching. Regencell’s formulae aim to improve blood flow to the brain and remove blood clot over time, thereby alleviating symptoms such as inflexibility and twitching. The TCM Practitioner also believes that as the child's heart is strengthened, more blood is delivered to the brain, resulting in an improved ability to focus.
All patients orally consumed the standardized TCM formulae twice daily for 3 months. Improvements in patients’ symptoms were assessed weekly during treatment review sessions with the TCM Practitioner and the children’s parents.
Second Efficacy Trial Results
Change in SKATBT-A3 scores
After 3 months of treatment, SKATBT-A3 scores of all patients were lower, indicating fewer problems and improvements in symptoms. Percentage improvement of patients ranged between 14% and 56%, with a mean of 37%.
There were noticeable improvements in the patients’ overall health, ADHD symptoms and ASD symptoms. Common improvements include better sleep quality, reduced temper, better bowel movement and healthier complexion. The most notable improvement were demonstrated by two patients who gained the ability to control their tongues naturally without the aid of their own hands after the 3-month treatment. This is noteworthy because limited tongue function affects verbal communications and language abilities.
Change in VADRS scores
After 3 months of treatment, the VADRS scores of 5 patients were lower, indicating fewer problems and improvements in symptoms, while 1 patient’s score remained the same and 1 patient’s score was higher. Percentage improvements of patients ranged between -21% and 62%, with a mean of 21%.
Change in ATEC scores
After 3 months of treatment, the ATEC scores of all patients were lower, indicating fewer problems and improvements in symptoms. Percentage improvement of all patients ranged between 4% and 52%, with a mean of 22%.
Among the 4 subscales of ATEC, we saw the most significant drop in scores in the health/physical/behavior subscale. Constipation, sleeping problems, poor appetite, anxiety/fearfulness, and irritability are common issues among ADHD and ASD patients. Most of the patients suffered from these symptoms before the treatment but these symptoms improved after the treatment.
No adverse side effects
None of the patients experienced any adverse side effects after the 3-month treatment.
