Lab Analysis and Effectivity of Men’s Formula

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By Dr. Raphael Nyarkotey Obu, RND, PhD, FCNMP, MCNMP, MINI-EMBA, CaPTC, AACR

Men's Formula

Prostate cancer strikes a special chord with me; partly because it is a very aggressive type of cancer in black men. Besides, every man has a prostate, but every prostate doesn’t have to make every man’s life miserable. The prostate; though a small gland has a huge repercussions on the quality of life of a man if it goes wayward. Yet, men do not pay much attention to this very important gland.  It is really my hope that men would not keep ignoring their prostate glands and realize what they stand to gain from it if is in a good health. The male prostate gland naturally enlarges with age. The bigger it gets, the greater the chance that some of the cells in the prostate will turn cancerous.

Many patients with prostate cancer are commenced on hormonal therapy; this can achieve tumour suppression for a time period of months to years. When tumour suppression can no longer be achieved, the prognosis is bleak for these hormone refractory patients. As current regiments have only a transient effect, many of these patients seek alternative treatments. But these treatments should be based on science.

According to Ross and colleague (1994) Epidemiological studies in the USA have suggested a strong dietary factor in the development of prostate cancer.

Studies such as these points to the fact that dietary agents may help in preventing the occurrence or progression of this disease. This therefore points to the fact that the search for dietary or herbal supplements that could be used in the treatment of prostate cancer.  In Ghana, a variety of herbal therapies for prostate health are sold in Pharmacy shops and also advertised on the airwaves. Many of these treatments are used as dietary supplements by prostate disorders patients. Interestingly, most of these products are formulated by people who have no knowledge in Naturopathic Urology. Most of these locally manufactured prostate products also contain either single or two ingredients; you can’t go to war with such soldiers.

It may interests you to know that, the number of men opting for natural therapies for their prostate health in Ghana is alarming.  There is plenty of evidence to suggest that ‘watchful waiting’, changing your diet and seeking alternative, natural cures will produce benefits that far outweigh conventional medical procedures. In fact, statistics show that a high percentage of men diagnosed with prostate cancer ultimately die with it and not from it and as such aggressive treatment is unnecessary.

Studies that have been conducted on patients with prostate cancer have found no evidence that undergoing surgery or chemotherapy is in any way better than an overhaul in lifestyle and diet.

Considering most men are around 70 years old when diagnosed with prostate cancer the findings illustrate the benefits of changing their lifestyles and diet rather.

This is the foundation to develop a phytomedicine product for prostate health and immune booster for men with advanced prostate conditions. It is not a replacement for any conventional treatment for prostate cancer; but to help Ghanaian men reduce their risk of prostatic diseases, help those with localized prostate cancer considering  ‘watchful waiting’ to be able to make the right decision for some time before considering any aggressive treatment if need be. Also to help boost the immune system of men with advanced prostate cancer and deal with the side effect  of conventional treatment to help improve the quality of life of men with prostate diseases.

Men’s Formula Tea manufactured by RNG Medicine Research Lab in Ghana is a combination of fourteen (14) herbs sourced from Ghana. The product has undergone Lab analysis at the Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, as part of the Food and Drugs Authority requirements for herbal products registration using animal studies.

The Faculty of Pharmacy and Pharmaceutical Sciences of the University employed three diverse protocols for the product analysis. The analysis, conducted through the Department of Pharmaceutics to assess the microbial loads, the Department of Pharmacology to assess the efficacy, acute and Sub chronic Toxicity test. Lastly, the Department of Pharmacognosy also assessed the phytochemical and physicochemical properties of the formulation.

The product showed an increase in total antioxidant capacity expressed as ascorbic acid equivalent. The total antioxidant capacity of ascorbic (0.01-0.3mg/ml)increased with increasing concentration (r2=0.9922)

As per the findings, Men’s formula Herbal Tea has antioxidant activity and hence would be of significantly relevant in prostate disorders. The No-Observable-Adverse-Effect level (OAEL) is greater than three times the stated daily dosage (7.0ml/kg) indicated by the manufacturer. The recommended daily dose is thus within the acceptable margin of safety.

  1. METHODOLOGY
  2. DEPARTMENT OF PHARMACOLOGY

Test Conducted: efficacy, Acute and Sub-Chronic Toxicity Test

Total Antioxidant Capacity Assay

The Department of Pharmacology of the Kwame Nkrumah University of Science and Technology conducted the efficacy, acute and sub chronic toxicity test on the product. Men’s Formula Herbal Tea extract (10mg) was combined with 3ml of reagent solution (0.6M sulfuric acid, 28mM Sodium Phosphate and 4mM ammonium molybdate). The tubes containing the reaction solution were incubated at 95oC for 90 minutes. The absorbance of the supernatant was then determined at 695nm against blank after cooling to room temperature. Distilled water (0.3ml) is processed as the extract and used as the blank. All measurements were done in triplicates. Data obtained for the ascorbic acid was analyzed as linear regression of the absorbance against concentration from which ascorbic acid equivalents were obtained and data obtained expressed graphically as column graphs of concentration against ascorbic acid equivalents (Total antioxidants capacity)

Reducing power

Various concentrations of an extract of Men’s Formula Herbal Tea(0.1. 0.3mg ml-1, in methanol) was mixed with 2.5ml of 0.2 M sodium phosphate buffer(pH 6.6) and 2.5ml1%  potassium ferricyanide solution in a test tube. The mixture was incubated at 50oC for 20 min, Trichloroaceticacid (10%; 1.5ml) was then added to the mixture and centrifuged at 650g for 10minutes. Two and a half milliliters (2.5ml) of the supernatant was mixed with 2.5ml distilled water and 0.5ml of 0.1% ferric chloride solution. The absorbance was then measured at 700nm using the spectrophotometer. Blank samples were prepared as follows: 1 ml distilled water was added to 2.5ml sodium phosphate buffer and 2.5ml potassium ferricyanide and the mixture processed as above. Vitamin E (0.1, 0.3, 1,3mgml-1, in methanol) was used as standard antioxidant. Each test was done in triplicate. The greater the reducing power, the higher the absorbance. Data was presented as concentration-absorbance curves and the EC50(concentration that gives 50% of maximal response)computed.

RESULTS

Total antioxidant capacity

Men’s Formula Herbal Tea (0.3-10.0mg/ml)also showed an increase in total antioxidant capacity expressed as ascorbic acid equivalent. The total antioxidant capacity of ascorbic acid (0.01-0.3mg/ml)increased with increasing concentration(r2=0.9922)

Reducing power

Men’s Formula Herbal Tea(0.1-3mg ml-1) and the standard antioxidant-tocopherol(0.1-3mg ml-1) dose-dependently reduced Fe3+ to Fe2+ as indicated by a dose-dependent increase in absorbance. From EC50(in mg ml-1) obtained for Men’s Formula Herbal Tea (10.4 ± 1.42) and tocopherol (18.8 ± 4.29)

Toxicity Test

Species

And strain

No. of animals

Sex/group

Route of Administration Formulations

And Dosage

Time of Deaths and Period of observation NOAL Symptoms
Sprague-Dawley

rats

25 males

 

5 groups

(N-5

Oral Decoction 10, 30, 100, 300, 1000mg/kg No death occurred during the period of observation: 24h and 30 days >100mg/kg Nil

NOAEL: No-Observable –Adverse-Effect Level Tab. 1

 

REMARKS

The result revealed that Men’s Formula Herbal Tea has antioxidant and hence would be of significant relevance in prostate disorders. The OAEL is greater than three times the stated daily dosage indicated by the manufacturer. The recommended dose is thus within acceptable margin of safety.

 

  1. DEPARTMENT OF PHARMACEUTICS.

 

  1. MICROBIAL ANALYSIS TEST CONDUCTED.

Microbial Test Protocol-(BP Level of Microbial Contamination)

  1. Assessment of total viable count of aerobic bacteria and fungi
  2. Test for specific harmful organisms.

 

Level of microbial contamination

i.                    The total aerobic viable count of sample(BP 2015 Specification-< 1 x10 cfu/mL 1.81 10 cfu/mL
ii.                  Test for Ecsherichia coli -MAC/37C/48hrs

(BP 2015 Specification-Nil/Ml)

 None detected
iii.                Test for Staphylococcus aureus-MSA/37C/48hrs

(BP 2015 Specification-Nil/mL)

None detected
iv.                 Test for Salmonella spp.BSA/37C/48hrs

(BP 2015 Specification-Nil/ mL)

None detected
v.                   Test for Pseudomonas aeruginosa/PCA/37C/48hrs

(BP 2015 Specification -Nil/ mL)

None detected
vi.                 Test for Yeast and Moulds-SB/25/C/5days

(BP 2015 Specification-< 1 x10 cfu/mL

9.30 x10 cfu/mL

 

  1. REMARKS

The findings revealed that the bacterial load obtained for the aerobic viable count was within the acceptable limit. The fungal load was within the acceptable limit (BP 2015). No harmful microorganisms were detected

  1. DEPARTMENT OF PHARMACOGNOSY

PHYTOCHEMICAL AND PHYSICOCHEMICAL ANALYSIS

  1. ORGANOLEPTIC PROPERTIES
Form Tea
Colour Brown
Taste bland
Odour Characteristic

Tab 3

  1. PHYSICOCHEMICAL PROPERTIES.
PH( aqueous decoction.) 5.10
Total ash not more than 1.89w/w
 Water –soluble extractive not less than 8.46% w/w
Moisture Content 4.15 w/w

Tab 4

iii.        PHYTOCHEMICAL PROPERTIES

Reducing sugars Positive
Saponins positive
Tannins positive
Alkaloids positive
Flavonoids positive
Sterols Negative
Terpenoids Positive

 Tab 5

  1. CHROMATOGRAPHIC PROFILE
Stationary phase Pre-coated silica gel plates
Detecting reagent Anisaldehyde
Sample used Chloroformic extract
Mobile phase chloroform Pet ether

9: 1

Tab 6

 

  • RESULTS – four(4) spots were observed after

Spraying and gently warming

-one (1) pinkspot(Rfs=0.86)

-Two (2) brownspots (Rfs= 0.73 & 0.44)

-one (2) purple spot ( Rfs=0.27)

 

Dr Raphael Nyarkotey Obu

Men’s formula is FDA certified with no FDA/HD1. 18-11342 herbal products for prostate health and immune booster for men with advanced prostate conditions. It is also formulated to support the general wellness of men and improve sexual vitality.

 

 

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