DepressionNCT01006460
A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed
A study testing Rhodiola rosea, L, Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis and Panax ginseng in people with Depression and Stress, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Depression, Stress
- What is being tested?
- Rhodiola rosea, L, Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis and Panax ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home.
Who cannot join
- suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease.
- with a psychiatric diagnose, using narcotics or suffering from HIV.
- with known allergy to any of the study medications.
- misusing euphorizing or pain killing drugs
- having used any adaptogenic product the last 2 months.
- having used cortisol or any other corticosteroid products the last 6 months
- being pregnant or breast-feeding
- which at the first interview are judged to be not cooperative or not to be able to finalize the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Biochemistry, Frederikbergs Hospital
Frederiksberg, 2000
About this study
Official title: A Randomized, Placebo Controlled, Parallel, Double Blinded Trial With Rhodiola Rosea Extract SHR-5 (Arctic Root) Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed
This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.
- Conditions
- Depression, Stress
- Being tested
- Rhodiola rosea, L, Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis, Panax ginseng, Placebo - dark brown sugar
- Keywords
- Quality of life and subjective well-being in middle aged women
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhodiola rosea, LDrug
3 Capsules twice a day
Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensisDrug
3 capsules twice a day
Panax ginsengDrug
3 capsules twice a day
Placebo - dark brown sugarDrug
3 capsules twice a day
| Study group | Role | What they receive |
|---|---|---|
| Adapt 232 | Experimental | Not described Receives: Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis |
| Arctic root group | Experimental | Not described Receives: Drug: Rhodiola rosea, L |
| Ginseng group | Active comparator | Not described Receives: Drug: Panax ginseng |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo - dark brown sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention
Measured: Over a period of 28 days of treatment
Secondary outcomes (2)
Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI).
Measured: over a period of 28 days of treatment
Quality of Life parameters: changes in quality of life as measured by the SF-36 scale, Danish Stress Profile (SP) test and questions regarding various aspects of well-being as formulated in a non-validated VAS scale
Measured: Over a period of 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kaj Winther, Dr, Principal investigator, Clinical Biochemistry department, Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006460
- Sponsor's protocol ID
- SHR5/DK
- Status last verified
- Nov 2009
- First submitted
- 1 Nov 2009
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Parallel, Double Blinded Trial With Rhodiola Rosea Extract SHR-5 (Arctic Root) Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed
- ClinicalTrials.gov ID
- NCT01006460
- Acronym / sponsor ID
- SHR5/DK
- Conditions
- Depression, Stress
- Keywords
- Quality of life and subjective well-being in middle aged women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adapt 232 | Experimental | Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis |
| Arctic root group | Experimental | Drug: Rhodiola rosea, L |
| Ginseng group | Active comparator | Drug: Panax ginseng |
| Placebo group | Placebo comparator | Drug: Placebo - dark brown sugar |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home.
Key exclusion criteria (8 listed)
- suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease.
- with a psychiatric diagnose, using narcotics or suffering from HIV.
- with known allergy to any of the study medications.
- misusing euphorizing or pain killing drugs
- having used any adaptogenic product the last 2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhodiola rosea, L3 Capsules twice a day | Drug | Arctic root group |
| Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis3 capsules twice a day | Drug | Adapt 232 |
| Panax ginseng3 capsules twice a day | Drug | Ginseng group |
| Placebo - dark brown sugar3 capsules twice a day | Drug | Placebo group |
Primary outcome
Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention
Time frame: Over a period of 28 days of treatment
2 secondary outcomes
Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI).
Time frame: over a period of 28 days of treatment
Quality of Life parameters: changes in quality of life as measured by the SF-36 scale, Danish Stress Profile (SP) test and questions regarding various aspects of well-being as formulated in a non-validated VAS scale
Time frame: Over a period of 28 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaj Winther, Dr principal investigator
Clinical Biochemistry department, Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhodiola rosea, L, Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis and Panax ginseng in people with Depression and Stress, run by Frederiksberg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention (time frame: Over a period of 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.