Psycho-Babble Medication Thread 854119

Shown: posts 1 to 5 of 5. This is the beginning of the thread.

 

another weird clinical trial

Posted by mike1975 on September 25, 2008, at 21:33:56

Guys,

I found this:

Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

This study is currently recruiting participants.
Verified by Mount Sinai Hospital, Canada, August 2007

Sponsored by: Mount Sinai Hospital, Canada

Information provided by: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT00446719

Purpose
We hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life.

Twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various meaures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.

Condition Intervention Phase
Depression
Drug: fertilized egg extract (Rellidep)
Phase II
Phase III


MedlinePlus related topics: Antidepressants Anxiety Depression

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (FEE- Fertilized Egg Extract) in Major Depressive Disorder


Further study details as provided by Mount Sinai Hospital, Canada:


Primary Outcome Measures:
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
1. Clinical Global Impression-Severity and Improvement [ Time Frame: 8 weeks ]

Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks [ Time Frame: 8 weeks ]

Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks [ Time Frame: 8 weeks ]

Beck Depression Inventory Scale (BDI) a t 8 weeks [ Time Frame: 8 weeks ]

Hamilton rating scale for Anxiety (HAM-A)at 8 weeks [ Time Frame: 8 weeks ]


Estimated Enrollment: 25
Study Start Date: August 2007
Estimated Study Completion Date: December 2007

Detailed Description:
Rellidep is an extract of fertilized hen's eggs which is relatively inexpensive and free of adverse metabolic or psychological side-effects. It has been shown in some clinical situations to improve a number of mood parameters. Its only known contraindication is an allergy to hens' eggs.

A number of published and anecdotal clinical studies in humans have used fertilized chicken egg extract for different indications. This extract was trialed as an anti-cancer agent by Davidson who injected it subcutaneously into mice and noted a reduction in tumour size. In his publications he also cited response in human subjects. Not only did Davidson note reduction in tumour size, his patients suffered no ill effects from the treatment.

In clinical trials of FEE to stimulate sexual interest the majority of subjects reported increased well being, enhanced sexual responsiveness, improvement in self-esteem and an increased level of happiness.

If sexual dysfunction is improved there could naturally follow an improvement in overall mood and lifting of depression. The reverse might be equally as persuasive an argument or more so, i.e. if the mood is enhanced by the lifting of depressive or negative feelings of sadness, anxiety or dysthymia, there then could follow enhanced sexual responsiveness. Rellidep therefore, has the capacity to improve mood. Testing this in controlled clinical trials is the logical next step.

In an unpublished European pilot study 18 subjects diagnosed with depression were treated with approximately 1700 mg daily of an extract of fertilized chicken eggs to assess its antidepressant activity.

The study ran for 8 weeks with depression parameters measured at baseline, 3 weeks and 8 weeks. The scales used were MADRS (score range 0-6) and a variation of the PTSF10 scale (score range 0-7).

At baseline the mean MADRS score was 20. By week 3 the score had fallen to 12 (a 43% reduction) and by week 8, there was a further fall to 9 (a 55% reduction). The 3 most responsive subjects, all of whom were deemed to be suicidal, had a mean score of 34 at the outset which fell to 7 at 8 weeks, representing an 80% reduction in their symptomatology.

The changes in the modified PTSF scale (PTSF10 + 5 additional questions) were inconsistent but there appeared to be a general downward trend.

Study Objectives

Primary Objectives: To evaluate the safety and efficacy of Rellidep 2000 mg/day in the management of Major Depressive Disorder in a psychiatric clinic setting. Secondary Objectives: To evaluate the effect of Rellidep on anxiety and quality of life in the management of Major Depressive Disorder.

...I would give it a try. You never know. I just have no idea where to get it.

Mike

 

Re: another weird clinical trial

Posted by desolationrower on September 25, 2008, at 23:11:37

In reply to another weird clinical trial, posted by mike1975 on September 25, 2008, at 21:33:56

hm, wonder if it is as good as essence of chicken.

Effect of Taking Chicken Essence on Stress and Cognition of Human Volunteers

SUMMARY
Stress is a common phenomenon. Every individual experiences it. There are many ways of combating stress. Stress is necessary for preparation against challenging situations and danger. It is necessary to have stress before a test so that we are prepared. For instance, stress actually motivates students to prepare for examination but excessive stress can lead to poor performance. This study evaluates the effect of a commercial essence of chicken (CEC) on the various parameters related to stress and cognition of human volunteers. CEC is produced by a hot-water extraction process from chicken meat under high pressure condition. It contains concentrated amounts of proteins, amino acids and peptides such as carnosine compared to homemade traditional chicken soup. Due to the unique extraction process, it has been postulated that readily absorbed amino acids and bioactive peptides are present in CEC. In this experiment, we evaluated the effect of CEC in comparison with a placebo and carageenan on a group of stressed medical students before their examinations. Students were divided into three groups at random and given either CEC, placebo or a carageenan drink daily for two weeks. Before and after the two weeks, the students were given a series of tests to assess their mental and physical well-being as well as attention and memory. The tests were the general health questionnaire (GHQ), SF36, digit span, construction of figures, 3-min memory test, comprehension and mental arithmetic. The students who ingested essence of chicken fared significantly better than the other two groups of students. The ability of essence of chicken to control anxiety by distraction and promoting attention and memory is discussed.

Effect of Oral Feeding of Essence of Chicken on the Level of 5-Hydroxyindoie Acetic Acid in the Cerebrospinal Fluid of the Rat
Abstract
The effect of oral feeding of a commercial preparation of essence of chicken (Brand's Essence of Chicken, BEC) on the level of 5-hydroxyindole acetic acid (5-HIAA) in the cerebrospinal fluid (CSF) of the rat was investigated. BEC, when fed to the rat for a period of 3 days, significantly increased the CSF level of 5-HIAA in seven out of 12 animals studied. As the level of CSF 5-HIAA is taken as an indication of 5-hydroxytryptamine (5-HT) activity in the brain, it is possible that BEC increased brain 5-HT activity. This increase was not due to the ingestion of tryptophan, the primary precursor of 5-HT, because BEC contains undetectable level of tryptophan. The data indicate that by causing an increase in brain 5-HT activity, consumption of BEC may lead to the activation of 5-HT-dependent physiological process like sleep improvement, mood elevation, analgesia, facilitation of motor output and regulation of circadian rhythm. However, such a possibility remains to be further investigated.


Effects of Chicken Extract on the Recovery from Fatigue Caused by Mental Workload
Abstract:
Folk wisdom suggests that chicken extract is useful for recovery from physical and mental fatigue. To explore this question, the physiological effect of Brand's Essence of Chicken (BEC), a popular chicken extract used as a traditional remedy, was assessed during recovering from mental stress. We quantitated the blood levels of stress-related substances, and examined the task performance and subjects' mood states during mental workloads. Subjects were 20, healthy male students who have never tasted BEC. They took two bottles of BEC or a placebo (70 ml/bottle) daily in the morning for 7 days. On the final experimental day, two mental workload tests were performed: (A) a mental arithmetic test (MAT; 1600 trials of two or three figure-addition or subtraction for 40 min). (B) a short-term memory test (SMT; 20 trials of memorizing 9 digit numbers). Blood was collected before and after each workload task. After the mental workload, the recovery of mean cortisol level of subjects who consumed BEC was significantly faster than that for those consuming the placebo. The task performance of subjects performing the MAT and SMT was also improved with BEC consumption compared with placebo. According to the profile of mood state questionnaire, subjects felt more active and less fatigued during the workload when they took BEC regularly. We conclude that the extract of chicken has the potential to metabolize stress-related substance in blood and to promote recovery from mental fatigue.
Clinical study on the combined effect of capsaicin, green tea extract and essence of chicken on body fat content in human subjects.
Abstract:
A study was conducted to assess the body fat content of free-living healthy human subjects taking a health supplement containing 0.4 mg capsaicin, 625 mg green tea extract (125 mg catechins and 50 mg caffeine) and 800 mg essence of chicken (CGTE). The subjects were advised to maintain their regular dietary habits and routine physical activity throughout the study duration. Their body fat content was measured before and throughout the trial duration using a hand-grip body fat monitor. After 2 weeks of supplementation with CGTE, the mean body fat percentage of male and female subjects was significantly less than the initial value (P<0.05; t-test). 70.6% of volunteers showed a trend for decreasing body fat content with 4 subjects showing a significant decrease in body fat content over time. The findings suggested that the effects were more prominent in subjects with higher initial body fat content. It was also demonstrated that the resting energy expenditure (REE) of the subjects taking the test samples were significantly increased in groups supplemented with CGTE, compared to placebo group. Thus, the combined thermogenic effect of capsaicin, green tea extract and essence of chicken could translate to a positive clinical effect by reducing approximately 460 g of body fat, following 2 weeks of supplementation and the application of this natural health supplement for excess fat regulation, should be considered.

-d/r

 

Re: another weird clinical trial

Posted by Phillipa on September 26, 2008, at 0:28:17

In reply to Re: another weird clinical trial, posted by desolationrower on September 25, 2008, at 23:11:37

Well now it's chickens? soon the ad will be chicken soup. Just kidding maybe. Phillipa

 

Re: another weird clinical trial

Posted by davea0511 on May 25, 2010, at 15:09:49

In reply to another weird clinical trial, posted by mike1975 on September 25, 2008, at 21:33:56

You don't need Rellidep. Humanofort is basically the same thing. Another version is "Young Tissue Extract".

Basically in all cases they wait until 9 days after a chicken egg is fertillized (halfway into it's incubation), then crack open the egg, smash it up, strain out the chunks, centrifuge out the stuff they don't need, and freeze dry the rest and put it in capsule form. It has pretty awesome properties and no side effects (although I have heard of headaches - related to the high protein intake - might be mitigated somehow).

IMHO it's worth a shot.

> Guys,
>
> I found this:
>
> Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder
>
> This study is currently recruiting participants.
> Verified by Mount Sinai Hospital, Canada, August 2007
>
> Sponsored by: Mount Sinai Hospital, Canada
>
> Information provided by: Mount Sinai Hospital, Canada
> ClinicalTrials.gov Identifier: NCT00446719
>
> Purpose
> We hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life.
>
> Twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various meaures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.
>
>
>
> Condition Intervention Phase
> Depression
> Drug: fertilized egg extract (Rellidep)
> Phase II
> Phase III
>
>
>
> MedlinePlus related topics: Antidepressants Anxiety Depression
>
> U.S. FDA Resources
>
> Study Type: Interventional
> Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
>
> Official Title: An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (FEE- Fertilized Egg Extract) in Major Depressive Disorder
>
>
> Further study details as provided by Mount Sinai Hospital, Canada:
>
>
> Primary Outcome Measures:
> 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks [ Time Frame: 8 weeks ]
>
>
>
> Secondary Outcome Measures:
> 1. Clinical Global Impression-Severity and Improvement [ Time Frame: 8 weeks ]
>
> Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks [ Time Frame: 8 weeks ]
>
> Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks [ Time Frame: 8 weeks ]
>
> Beck Depression Inventory Scale (BDI) a t 8 weeks [ Time Frame: 8 weeks ]
>
> Hamilton rating scale for Anxiety (HAM-A)at 8 weeks [ Time Frame: 8 weeks ]
>
>
> Estimated Enrollment: 25
> Study Start Date: August 2007
> Estimated Study Completion Date: December 2007
>
> Detailed Description:
> Rellidep is an extract of fertilized hen's eggs which is relatively inexpensive and free of adverse metabolic or psychological side-effects. It has been shown in some clinical situations to improve a number of mood parameters. Its only known contraindication is an allergy to hens' eggs.
>
> A number of published and anecdotal clinical studies in humans have used fertilized chicken egg extract for different indications. This extract was trialed as an anti-cancer agent by Davidson who injected it subcutaneously into mice and noted a reduction in tumour size. In his publications he also cited response in human subjects. Not only did Davidson note reduction in tumour size, his patients suffered no ill effects from the treatment.
>
> In clinical trials of FEE to stimulate sexual interest the majority of subjects reported increased well being, enhanced sexual responsiveness, improvement in self-esteem and an increased level of happiness.
>
> If sexual dysfunction is improved there could naturally follow an improvement in overall mood and lifting of depression. The reverse might be equally as persuasive an argument or more so, i.e. if the mood is enhanced by the lifting of depressive or negative feelings of sadness, anxiety or dysthymia, there then could follow enhanced sexual responsiveness. Rellidep therefore, has the capacity to improve mood. Testing this in controlled clinical trials is the logical next step.
>
> In an unpublished European pilot study 18 subjects diagnosed with depression were treated with approximately 1700 mg daily of an extract of fertilized chicken eggs to assess its antidepressant activity.
>
> The study ran for 8 weeks with depression parameters measured at baseline, 3 weeks and 8 weeks. The scales used were MADRS (score range 0-6) and a variation of the PTSF10 scale (score range 0-7).
>
> At baseline the mean MADRS score was 20. By week 3 the score had fallen to 12 (a 43% reduction) and by week 8, there was a further fall to 9 (a 55% reduction). The 3 most responsive subjects, all of whom were deemed to be suicidal, had a mean score of 34 at the outset which fell to 7 at 8 weeks, representing an 80% reduction in their symptomatology.
>
> The changes in the modified PTSF scale (PTSF10 + 5 additional questions) were inconsistent but there appeared to be a general downward trend.
>
> Study Objectives
>
> Primary Objectives: To evaluate the safety and efficacy of Rellidep 2000 mg/day in the management of Major Depressive Disorder in a psychiatric clinic setting. Secondary Objectives: To evaluate the effect of Rellidep on anxiety and quality of life in the management of Major Depressive Disorder.
>
> ...I would give it a try. You never know. I just have no idea where to get it.
>
> Mike

 

Re: another weird clinical trial » davea0511

Posted by Deneb on May 27, 2010, at 21:32:35

In reply to Re: another weird clinical trial, posted by davea0511 on May 25, 2010, at 15:09:49

Hello davea0511!

Welcome to Psycho-Babble! This thread started 2 years ago so you may not get responses from those posters.

Feel free to start your own threads.

Deneb


This is the end of the thread.


Show another thread

URL of post in thread:


Psycho-Babble Medication | Extras | FAQ


[dr. bob] Dr. Bob is Robert Hsiung, MD, bob@dr-bob.org

Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.