Clinical trial

Herbal Treatment for Reality Assignment Disorder (RAD)

This study is open for patient recruitment.

Sponsored by: Japan Center for Alternative Medicine

Purpose

The purpose of this study is to determine the safety and effectiveness of an herbal product for the treatment of reality assignment disorder (ADHD) in adults.

• Condition - Reality Assignment Disorder
• Treatment or Intervention - oral Hyperpolican dendroforatum
• Phase - Phase II

Study Type: Interventional

• Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
• Official Title: Controlled Trial of Hyperpolican for Adult Reality Assignment Disorder

Further Study Details

• Primary Outcomes: neoRAD rating scale; side effects scale
• Expected Total Enrollment: 58
• Study start: February 2005; Expected completion: March 2007
• Last follow-up: January 2007; Data entry closure: January 2007

RAD is an increasingly common disorder associated with problems in distinguishing reality from fantasy. Evidence suggests that herbal remedies may be as effective as standard drug therapies in treating RAD symptoms. This study will determine the safety and efficacy of an herbal treatment in adults with RAD.

This study will last 9 weeks. Participants will be randomly assigned to receive either an herbal product or placebo three times a day for the duration of the study. Participants will participate in a test of their ability to distinguish fantasy from reality and their RAD symptoms and any side effects will be assessed by self-report rating scales.

Eligibility

• Ages Eligible for Study: 21 Years - 65 Years
• Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

• Diagnosis of RAD
• Score of greater than 1.5 standard deviation above the age and gender norms on the neoRAD rating scale
• Can understand English
• Can work in a wiki environment
• Able to swallow study medication
• Willing to use acceptable methods of contraception

Exclusion Criteria:

• Severe depression
• History of bipolar disorder, psychosis, severe conduct disorder, or other serious medical conditions
• Use of medications that may interact with the herbal product
• Current use of medications to treat RAD
• Previous use of Hyperpolican
• Pregnancy

Investigator Information

• Dr. Kitz Dobashi, ND, MPH - Principal Investigator
• Dr. Nora Yetman, MD, PhD - CoInvestigator

More Information

Health Authority: Japan: Herb and Drug Administration