In order to demonstrate the effectiveness of DigestaCure® AUTOIMMUNE-X®, we have proceeded with Phase 2 and Phase 3 Trials, which have shown incredibly encouraging results, prompting Phase 4 Trials to be conducted, obtaining data from patient files of doctors and natural healing practitioners using the formulation in their practices.
We have had over 20 years of success, treating patients with chronic diseases or autoimmune conditions, with immune modulators.
Hence, in the Phase 2 trial, our objective was to demonstrate the period of time required for healing, as well as the therapeutic improvement, in patients suffering from diagnosed autoimmune diseases, through the administration of low doses of the formula, thereby confirming its safety and nontoxic properties.
A. The Method of the Study for Phase 2 Clinical Trials
1. Method of Data Collection
- Most patients start taking DigestaCure® AUTOIMMUNE-X® as they suffer from the long-term symptoms of autoimmune diseases or from the side effects of pharmaceutical medications used to treat them.
- The 186 participants chosen for the Phase 2 Clinical trial were males and females, from varying age groups, who exhibited symptoms of autoimmune diseases at differing levels of intensity and progression, over a period of 12 months beginning in March 2015.
- Like all patients who opt to take the formula, they were encouraged to take doses prescribed, consistently, communicate with the support team and voluntarily submit standardized electronic Progress Submission Forms, monthly, during their treatment. Each person’s report represented one month of their healing period.
- Excluding their personal information, all other data received through these reports was compiled, analyzed, and categorized.
- Progress Submission Forms rejected were duplicate forms, and forms left incomplete in critical areas such as; number of months taking, dosages being taken, and percentage of improvement experienced.
2. Study Structure
a. Participants protected from knowledge of clinical testing:
Participants purchased the formula on their own and were unaware that their submitted data would be part of a clinical trial, avoiding potential bias in their progress reports.
b. Physicians unaware of Clinical Testing:
Most of the participants’ doctors were unaware that their patients were taking immune modulators and that their data would be part of a clinical trial. Minimal physician encouragement and negative reinforcement to participants would nullify any “placebo effect.
c. Placebo free trial:
A review of the double-blind study method shows that placebos have created a false sense of security in research. The worsening of patient’s conditions while on placebos during a trial is demoralizing.
To obtain approval of patented drugs, this method is touted by the pharma/medical industries as the “gold standard”. The goal is to demonstrate an improvement in symptom relief, between the placebo and the drug being tested. A 10% margin is considered significant to gain approval, if adverse reactions are at acceptable levels.
However, according to a study from Johns Hopkins University, the drug industry is now the third leading cause of deaths in the US. Some of these deaths occur during double-blind studies, either due to patients succumbing to their illness while on the placebo or dying from adverse reactions of the drug.
In our humble opinions, healing the patient without harm should be the gold-standard, and healing incurable diseases should be the Platinum Standard, which involves the administration of an effective and harmless substance, to all the study participants.
3. Patients included, excluded or discontinued from the study
- 50 % of participants, instructed to raise dosages from 8 to 12 capsules per day during the healing process could not do so, due to personal financial restrictions. Half of them showed 20-50% therapeutic improvement at the time they dropped out. This obstacle may be overcome once insurance coverage is obtained.
- Some participants did not submit updated reports during or after their healing periods. Reductions in symptoms, especially pain, encourages non- compliance as patients discontinue treatment prematurely, without consulting doctors.
4. Analysis and Interpretation of Results
Flavianny Santos, CCRC (Certified Clinical Research Coordinator), Andrea Larsen (Medical Research Coordinator/Licensed Nutritionist), the Phase 2 statisticians mentioned that because autoimmune conditions addressed in this study are considered incurable, consistent improvements in any of them, are profound, and levels of progress, evaluated through the data, are considerable.
The diagram below, illustrates that the healing process builds up over time, without any adverse reactions. However, the 12-month interval demonstrated is not relevant as with changes in the dosages, time frames can be accelerated to give faster and better results.
B. Dosage of the medication and the consequences on therapeutic efficacy
Method of Ingestion: The formula is available as capsules. The contents can be mixed with water, or they may be swallowed. It may be taken with or without food.
The Standard Dosage Procedure: starts with 1 capsule on Day 1, increasing by one capsule per day, reaching 8 capsules per day on Day 8. The average therapeutic dose continued, is between 8-12 capsules per day, evaluated periodically for adjustments.
The data indicates that consistent treatment leads to greater therapeutic improvement.
12 Capsules daily yielded a nearly 15% greater therapeutic improvement across the months of the healing phases, as compared to 8 capsules daily.
|No of partients||Dosage / Healing phase||% Therapeutic Improvement|
|99||8 capsules per day||35.95% per person|
|47||12 capsules per day||41.27 % per person|
|14||8 to 12 months||77.85% per person|
|7||10-12 months||81.42% per person|
C. Additional Observations
- On occasion, a tough case has responded after 8 months of treatment.
- In non-responsive cases, with higher daily dosages of 18 to 24 capsules (9 to 12 grams) 4 out of 5 show therapeutic improvement within one month.
- We believe that limited or damaged receptor sites (enterons) within some patients’ small intestinal tracts, may play a role in the amount of formula absorbed.
- Using higher levels of the immune modulators increases chances of the remaining functioning enterons catching and absorbing a modulator, thereby improving efficacy.
D. Maintenance Doses
Once the patient has recovered, dosage levels required to maintain healthy immune function and to prevent recurring symptoms may vary, but in most cases, are much lower than the standard dosage levels.
E. Dosages to Avoid Herxheimer Reactions (Detoxification or Healing Crisis)
Herxheimer Reactions or “detoxification symptoms” can be a concern for “highly toxic” or “super- sensitive” individuals, lasting from a few minutes to a few hours, without harming tissues or cells.
The formulation for immune modulators is anti-fungal, anti- viral, anti- bacterial, and anti-parasitic. In order to avoid symptoms of rapid “die-off,” of these microorganisms, we eliminate disease-causing pathogens gradually.
|The Very Gradual Step-Up Dosage Procedure is done over 4 days to ensure that the body gets acclimatized to the healing process.|
|Day of Treatment||Dosage||Medium of Ingestion|
|Day 1 to Day 4||1/8 capsule||Contents shaken in water|
|Day 5 to Day 8||1/4 capsule||Contents shaken in water|
|Day 9- Day 12||1/2 capsule||Contents shaken in water|
|Day 13 to Day 16||1 capsule||Contents shaken in water|
What is DigestaCure® AUTOIMMUNE-X®? What is its mechanism of action?
After years of testing, Pristine Nutraceuticals discovered a combination of extracted, stabilized, and concentrated GRAS, USDA food materials, in precise proportions, which together may nudge the immune system out of the attack-mode of autoimmunity, and back into the state of normalcy, without any known contraindications with other medications.
This natural formula contains specific phytonutrients (mannans) derived from 20th generation aloe botanicals, which are processed and stabilized (preserved in biologically active form), through a unique proprietary method.
These include stabilized:
- long-chain polymannan and polysaccharide molecules
- mannose molecules
- glucomannans, glucopolymannans
- glycolipids, polysaccharides (oligosaccharides)
Identification of the problem:
Under a microscope, a fuzzy coating or glycocalyx is seen, surrounding the surface of immune killer cells. This is a coding system (a guidance system) which helps in cell communication.
It is made up of Immune Modulating Components (IMCs) which function like a “GPS SYSTEM” for immune killer cells so that they may find their target, the pathogen. When an adequate number of IMCs are present in the body, the immune cells are able to accurately locate and eliminate pathogens which promote illness and disease.
However, if the IMC levels are low or absent, the immune cells are unable to distinguish between pathogens and the body’s own cells and attack them instead. This is known as autoimmunity. Attacks in the joints are referred to as arthritis, those in the thyroid known as Hashimoto’s Thyroiditis or Grave’s Disease, and in the digestive tract may be ulcerative colitis or Crohn’s Disease.
Our Successful Healing Approach: As opposed to treating diseases, we supply the body’s immune system with required immune modulators, so that it can rectify auto-immune diseases on its own.
Over the past 20 years I have had the chance to witness the benefits of this formula in treating chronic degenerative or autoimmune diseases.
The data from Phase 2 and Phase 3 Clinical Trials also reflect the same, showing the potential DigestaCure® AUTOIMMUNE-X® has the ability to change the direction of modern medical treatment away from drug-based methodology to a harmless and effective natural therapeutic approach.