Contact information
Type
Scientific
Primary contact
Dr Ruotao Wang
ORCID ID
Contact details
Chinese Center for Disease Control and Prevention
27 Nan-wei Road
Beijing
100050
China
rtwang@chinaids.org.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The immune-stimulating effects of this proprietary botanical blend (Resistex®) may aid in resisting community-acquired respiratory viruses.
Ethics approval
At the time of the trial, ethics approval was not common in China and the regulations were not clear as to under what circumstances it was required. Therefore the Principal Investigator assembled a group of independent professionals to critically review the study protocol and the ingredients of the botanical formula (based on Chinese herbs), which was tested. They acted as the equivalent of an Institutional Review Board and determined that the study intervention was unlikely to pose any safety risk to the participants. This review took place in early 1998.
Study design
The study was a randomised, double-blind, placebo-controlled clinical trial that included
61 elderly participants.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Common cold and flu
Intervention
The 61 participants were randomised to the control (placebo) group or to the low dose or high dose treatment group of Resistex®. All three groups took their dietary supplement capsules just once a day. The low dose group took two 450 mg capsules (900 mg total); the high dose group took three 450 mg capsules (1350 mg); and the control group took three placebo (wheat starch) capsules. All were instructed to take their capsules as directed every day for the first four weeks.
This segment was followed by a one week break during which no capsules were taken, and all subjects received a health check-up by a physician. After the break, the subjects took their capsules as directed over a series of two-weeks on/one week off periods for a total of 4.5 months. [Note: These breaks are a normal practice in TCM; they are incorporated to allow the immune system to take a periodic break from the up-regulating effects of the herbs.]
Intervention type
Drug
Phase
Not Specified
Drug names
Resistex®
Primary outcome measures
The main outcome measures in this study were self-reports of the frequency, duration, and severity of cold and flu symptoms as compared with the pre-treatment assessment of the same variables. At the beginning of the study, all participants were queried about their cold and flu histories from the previous winter season (mid-November to end of March).
Cold and flu symptoms included: headache associated with fever; nasal discharge; sore throat; sneezing; and chills or fever. To help subjects determine the frequency of colds or flu, the following criteria were established:
1. Family physicians diagnosis of condition
2. Simultaneous experiencing of two or more symptoms within a week
3. Experiencing three or more symptoms without seeing a doctor.
The questions were:
1. How many times did you contract a cold or flu within the specified period?
2. When you had a cold or flu, how many days did it usually take before the symptoms were alleviated?
3. When you had a cold or flu, on a scale of one to five, how severe were the cold and flu symptoms? (1) barely noticeable, (2) mild, (3) moderate, (4) severe, (5) very severe
At the end of the study, the participants answered the same questions regarding the current winter season (mid-November to end of March).
Secondary outcome measures
The subjects were asked whether they experienced any adverse effects/reactions.
Overall trial start date
01/04/1998
Overall trial end date
31/03/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 60 to 80 years old
2. Having a normal clinical chemistry profile (tested at baseline)
3. Physician clearance
4. Willingness to be randomised to the treatment or placebo groups and adhere to all aspects of the study protocol
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Acute or serious chronic diseases
2. Currently taking prescription medication or non-steroidal anti-inflammatory drugs
3. Use of vitamin or mineral supplements within the past three months
4. A history of alcohol or drug abuse
5. Marked sleep disturbances, serious allergies or salient emotional or mood problems
6. A history of systemic infection, bone fracture or surgery
Recruitment start date
01/04/1998
Recruitment end date
31/03/1999
Locations
Countries of recruitment
China
Trial participating centre
Chinese Center for Disease Control and Prevention
Beijing
100050
China
Sponsor information
Organisation
Radix Bioresearch Corporation (USA)
Sponsor details
4436 Reeves Road
Suite A
Ojai
93023
United States of America
diana@radixbioresearch.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Financial support from Radix Bioresearch Corporation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary