Randomised, double blind, placebo-controlled trial for testing the efficacy of a botanical formulation in reducing cold and flu symptoms

ISRCTN	ISRCTN09166218
DOI	https://doi.org/10.1186/ISRCTN09166218
Secondary identifying numbers	N/A

Submission date: 08/09/2006
Registration date: 25/09/2006
Last edited: 27/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ruotao Wang
Scientific

Chinese Center for Disease Control and Prevention
27 Nan-wei Road
Beijing
100050
China

Email	rtwang@chinaids.org.cn

Study information

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
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	The immune-stimulating effects of this proprietary botanical blend (Resistex®) may aid in resisting community-acquired respiratory viruses.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Resistex®
Primary outcome measure	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 study start date	01/04/1998
Completion date	31/03/1999

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/04/1998
Date of final enrolment	31/03/1999

Locations

Countries of recruitment

China

Study participating centre

Chinese Center for Disease Control and Prevention

Beijing
100050
China

Sponsor information

Radix Bioresearch Corporation (USA)
Industry

4436 Reeves Road
Suite A
Ojai
93023
United States of America

Email	diana@radixbioresearch.com
"ROR"	https://ror.org/024hp8310

Funders

Funder type

Industry

Financial support from Radix Bioresearch Corporation (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan