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 |
| Protocol serial number | N/A |
| Sponsor | Radix Bioresearch Corporation (USA) |
| Funder | Financial support from Radix Bioresearch Corporation (USA) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Chinese Center for Disease Control and Prevention
27 Nan-wei Road
Beijing
100050
China
| rtwang@chinaids.org.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | The study was a randomised, double-blind, placebo-controlled clinical trial that included 61 elderly participants. |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Resistex® |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
The subjects were asked whether they experienced any adverse effects/reactions. |
| Completion date | 31/03/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
100050
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
