Condition category
Infections and Infestations
Date applied
08/09/2006
Date assigned
25/09/2006
Last edited
27/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 physician’s 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

Publication citations

Additional files

Editorial Notes