Evaluation of the Clinical Efficiency of an Antisickling Polyherbal Formula Drepanoalpha in a Sickle cell disease Patient in Gbado-Lite City (Democratic Republic of the Congo) by Quantum Magnetic Resonance Analyzer

Benjamin Gbolo Zoawe1,2, Koto-te-Nyiwa Ngbolua1,2,*, Pius T. Mpiana1,3, Ndanga Bikibo Appolinaire1, Pangodi Aundagba Jean-Marie1, Masengo Ashande Colette1, Mudogo Virima1,3 1 Research Group in "Ethnopharmacology and Unconventional Medicine", University of Gbado-Lite, Gbado-Lite, Democratic Republic of the Congo 2 Department of Biology, Faculty of Science, University of Kinshasa, Kinshasa, Democratic Republic of the Congo 3 Department of Chemistry, Faculty of Science, University of Kinshasa, Kinshasa, Democratic Republic of the Congo * Corresponding author: Prof. Koto-te-Nyiwa Ngbolua (PhD); jpngbolua@unikin.ac.cd

suggesting that this would be an epigenetic modulation of the gene. This medication is given after prior infusion of one to two teaspoons of the powder in boiling water and should be administered within hours of its preparation. The volume of administration is 20 mL with remarkable pharmacological effects in sickle cell patients [5][6][7][8][9][10][11]. However, conventional methods of assessing the therapeutic efficacy and safety of improved traditional drugs are expensive because of laboratory consumables (chemical reagents) and equipment, and which, in besides, do not exist in the universities of the hinterland; however, they must train community managers and conduct high-level scientific research in the absence of state and laboratory grants. For this purpose, quantum magnetic resonance (RMQ) is a technique of choice for monitoring treatment in order to disprove or confirm the therapeutic efficacy and safety of a phytodrug in patients. It is a fast, non-invasive and painless technique that does not use chemical reagents but simply exploits the body's electromagnetic properties using an electronic sensor coupled with the RMQ analyzer and a computer [12][13][14]. This study was initiated with the aim of validating and promoting the use of RMQ in the monitoring of phytotherapeutic management of sickle cell disease in African rural zones and also as a simple, robust, alternative and/or follow-up of clinical trials in sickle cell patients. Given the limitations of the use of conventional methods in assessing the clinical effectiveness of plant derived medicines in rural areas, RMQ can provide a unique opportunity. This study is a major contribution to clinical trials using an unconventional method. To the best of our knowledge, the evaluation of the therapeutic efficacy of Drepanoalpha by this unconventional methodological approach in a homozygous sickle cell disease (SCD) patient is an original strategy of clinical studies never carried for such screening in the DRC.

Place of study
This study was conducted in Gbado-Lite city in the Nord-Ubangi province (Figure 1) in the Democratic Republic of the Congo.

a. Sickle Cell Anemia Patient
The 13-year-old female patient (size: 110 cm; weight: 30 kg) was received in our research unit "Ethnopharmacology and unconventional Medicine" attached to the University Medical Center of University of Gbado-Lite, DRC in May 06, 2019 for painful seizures (vaso-occlusion) and hemolytic anemia. Result of Emmel test revealed SCD status. The SCD patient had received first aid at the Gbado-Lite General Reference Hospital (HGR) where he received symptomatic treatment. When he arrived at the University medical center, accompanied by his father, the hemoglobin level was 6% and the patient had splenomegaly and jaundice and has never been transfused since birth. His father admits to having previously submitted successfully her child to Drepanoalpha treatment in 2016 and that the child had no pain crisis longer known until he was admitted to HGR.

b. Drepanoalpha (An innovative antisickling polyherbal formula)
Drepanoalpha is an anti-sickle cell dietary supplement that supplements SCD patient nutrition with essential proteins and trace elements. His powder contains 17% proteins, 5.70% fat, 6% raw fibre and 55.33% carbon hydrates and presents an energy value of 1482.07 kJ.
In addition, this nutraceutical contains in its composition the iron (9.0 mg/100 g), magnesium (1.4 mg/100 g), calcium (4.8 mg/100 g), zinc, manganese, potassium, phosphorus and vitamin C. phytochemical Studies showed that anthocyanins and organic acids are the main active principles of Drepanoalpha. In addition, flavonoids are plentiful in Drepanoalpha and can be proposed as phytomarkers for quality control and the standardization of this dietary supplement. In addition to its nutritional properties, Drepanoalpha showed an ability to increase the hemoglobin level in vivo and antisickling activity (normalization rate: 80%), anti-hemolytic and antioxidant properties (DE50: 0.604 ± 0.028 µg/mL). Drepanoalpha reduces the frequency of sickle cell attacks and improves the general state of treated patients. With a lethal dose (DL50) greater than 4,000 mg/kg in the Wistar rat and 16,000 mg/kg in the guinea pigs, the product may be considered non-toxic under the normal conditions of its use. In addition, the product did not show any toxicity on immune cells and blood coagulation factors. Forits use, it is necessary to place in a cup about 80 mL boiling water and add the amount of the powder of Drepanoalpha corresponding to the patient's age, i.e. 1 to 2 teaspoons. After infusion for 30 minutes, the surnageant is collected after filtration using a tea sieve or a very clean cloth. The resulting infuse will be administered three times a day at a rate of 20 mL per intake. This infuse cannot be used beyond 24 hours after its preparation. To be effective, Drepanoalpha should be consumed continuously for at least 6 months; it was only after that will give the maintaining doses [5][6][7][8][9][10][11].

III. Methodology
The mini-quantum analyzer performs a systematic scan of the human body. Electromagnetic signals emitted by the human body (a reflection of its normal or pathological state) are collected by an electronic sensor, amplified and processed by a microprocessor. The data collected is then compared by the software with the RMQ spectrum based on the principles of Fourier serial decomposition.
The main elements of analysis relate to about 40 parameters, of which cardiovascular systems and cerebro-vascular, bone mineral density, trace elements, nerves cranial, the gastrointestinal function, function of the large intestine, liver function, gallbladder function, pancreatic function, kidney function, the pulmonary function, brain, bone growth index, the endocrine system, the immune system, etc. The test is done before the meal or an hour later in an elongated position as showed in figure 3 and by ridding the patient of any metal objects and other electronic devices. The patient takes in his left or right hand the electronic sensor coupled with the RMQ and a personal computer as described by the manufacturer of the RMQ device [12][13][14].The data was taken on D-day0 Base line and J21 post treatment. The duration of treatment was seven days (J1-J7).
After scanning the human body, the results are automatically displayed on the computer screen and can be recorded or printed.

IV. Discussion
The results of the RMQ analyses indicate that for some parameters, the values were not influenced by the taking of Drepanoalpha. While for others, the parameter values have been corrected from abnormally low or high values to normal benchmarks. These observations confirm the safety and therapeutic efficacy of Drepanoalpha in homozygous SCD patient as previously validated by conventional techniques in SS erythrocytes, rats; guinea pigs and homozygous SCD patients' model systems [6,8,10,11].   These values provide information on the state of the body or organ: healthy (normal value) or pathological condition (anomaly: abnormally low or high relative to normal/reference). This study revealed that Drepanoalpha is effective in vivo and has restored homeostatic balance by optimizing certain vital functions in the treated SCD patient. Indeed, Drepanoalpha has improved the function of the large intestine by normalizing the coefficient function of peristalsis function of the large intestine, the rate of absorption of the colon and the coefficient of bacteria. For the latter parameter the decrease in its value from 13,797 to 2,611 means that treatment with Drepanoalpha reduces the incidence of bacterial infections in the SCD patient. Taking the infused based nutraceutical improved the functioning of the cranial nerves and the memory index at the level of the patient's brain, bone mineral density. The polyherbal formula also helps to prevent rheumatism by improving the coefficient of hyperostosis and the coefficient of osteoporosis. Bone growth index values include bone alkaline phosphatase, osteocalcin, long bone healing status and epiphysic line; 17 mineral elements (Fe, Zn, Se, Cu, Co, Mn, I2, Ni, Fluore, P, K, Mg, Vanadium, Sn, Si, Sr and Bore); 8 vitamins (A, D3,E, K, B1,B3,B12,C); 5 coenzymes (biotin, pantothenic acid, folic acid, nicotinamide) and glutathione were standardized/normalized. It should also be noted that the consumption of Drepanoalpha also improved the endocrine system (thyroid index, adrenal gland index, pituitary secretion index, pineal secretion index, glandular secretion index, thymus) and the immune system (amygdala immune index, bone marrow index, spleen index: from 253,757 to 35,637, index of immune system, index of immune gastrointestinal tract) of the SCD patient.
The reduction in the index value of the spleen is evidence that Drepanoalpha reduced the rate of sickle cell disease in vivo and would therefore prevent splenic sequestration of sickle cell cars reported in the literature as a factor responsible for splenomegaly in SCD patients [15]. The results of this study also show that Drepanoalpha improves the physical quality base of sickle cell disease. Indeed, this phytodrug reduced the response capacity index (from 288,094 to 65,419) respectively, the lack of water (from 323,023 to 37,637) and Index of hypoxia (from1208, 137 to 141,467). This shows that Drepanoalpha improves the state of hydration and oxygenation ofsickle celletirocytics and confirms that the bioactive molecules contained in Drepanoalpha would inhibit on the one hand, falciformation by interfering with the polymerization of deoxyhemoglobin S and the Gardos canal reported in the literature as a factor implicated in erythrocytic dehydration [16] on the other hand.
The results of the RMQ analysis also indicate that Drepanoalpha prevents obesity in patients by reducing the lipid metabolism coefficient (from 3,954 to 3,708) and fat tissue colour coefficient (from 11,555 to 4,197).
Based on the results of this study, Drepanoalpha reduces proportion of collagen (at the level of certain systems and devices in the body) as well as the body's main and collateral channels; decreases systolic volume (from 195,026 to 67,882), low-density lipoprotein (C-LDL: from 7,301 to 1,578); estrogen (from 11,084 to 8,828), gonadotropin (from 20,534 to 8.93), prolactin (from 8,101 to 7,846), progesterone (from 64,712 to 16,724) and neurotransmitters (from 3,168 to 0.973).The standardization of C-LDL and neurotransmitters by Drepanoalpha allows trait prevent respectively atherosclerosis and inflammation in sickle cell disease. To this end, it should be noted that various inflammatory agents are often increased in SCD patients and are likely to cause a kidney dysfunction [17].

V. Conclusion
The aim of the present study was to evaluate the clinical efficacy of Drepanoalpha, an antisickle cell nutraceutical, in a homozygous SCD patient using the RMQ analyzer. The results show the relevance of the use of this unconventional analysis in the SCD patient under treatment. The RMQ analyzer being a reliable way to understand the body's disorders in a holistic way (deficiency, balance or excess), it can be validated as an appropriate and robust means for monitoring and evaluating the effectiveness of anti-sickle cell drugs in large-scale clinical studies (nutritherapy program) in rural areas. This device is not only fast, practical, economical, accessible, non-invasive but also easy to use and adapted for this category of research in underprivileged areas.