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Clinical Study: Pre-menopausal     

Product type : Botanical Pueraria Mirifica - Premium Grade
Function : Health Food (Food Supplement),   Test Period : 2 month,   Number of Testers : 31 Placebo   

32 consume 400 mg/day, 15 days/month,  34 consume 800 mg/day, 15 days/month,

The results are summarized in folowing details as in below;

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Efficacy test of Pueraria mirifica consumption
as food supplement or functional food in Premenopausal women
No.of Tester
34 person
 
32 person
 
31 person
 
Usuage per day
800 mg/day
Result
400 mg/day
Result
 Placebo
Result
Breast Enlargement
 28
 82.35%
 3
 9.38%
 -
0.00%
Breast Firmness
 30
 88.23%
 13
 40.62%
 -
0.00%
Healthier menstruation
 10
 29.41%
 2
 6.25%
 -
0.00%
Increase vaginal secretion
 29
 85.29%
 14
 43.75%
 -
0.00%
Charasma clearance
 4/4
 
 3/3
 
 -
0.00%
Healthier hair
 30
 88.23%
 24
 75.00%
 -
0.00%
Skin Recovery
 32
 94.11%
 28
 87.50%
 -
0.00%
Mammary pain
32
94.11%
14
43.75%
-
0.00%

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The placebo group contains 31 testers, had received tapioca starch filled capsule to consume 2 capsules/day for 15 days/month started from the first day of the menstruation period, for 2 consecutive months. This group showed no significance change in all record parameters.

The first tested group contains 32 testers, had received 200 mg @ 2 capsules each per day of Pueraria mirifica filled capsule in the same condition as the placebo group.

This group showed significance change with different number in all recorded parameters, including mammary pain (44%) which is related to brest firmness and may relate also to breast enlargement, skin recovering (88%), healthier hair (75%), charasma clearance (100%), increase vaginal secretion (44%), healthier menstruation (6%), breast fu-mness (44%), breast enlargement (9%), and hip enlargement (9%).

The second tested group contains 34 testers, had received 200 mg @ 4 capsule - Pueraria mirifica filled capsule to consume 4 capsules/day in the same condition as the placebo group.

This group showed significance change with higher number in all recorded parameters, including mammary pain (94%), skin recovering (94%), healthier hair (88%), charasma clearance (100%), increase vaginal secretion (85%), and thus could restore female potency in some tester, healthier menstruation (29%), breast fu-mness (94%), breast enlargement (88%), and hip enlargement (59%). Some testers claimed that the high blood cholesterol level is also decreased.

Conclusion

In conclusion, the human test as a food supplement or functional food product has shown its estrogenic effects clearly among testers, including skin refomed, hair complexity, breast firmness, and possible to induce breast enlargement..

 

Clinical Study: Menopausal
Clinical Trial of the Unique Phytoestrogen-rich Herb, Botanical Pueraria mirifica of Tropical Herbal Product as a Crude Drug in the Treatment of Symptoms in Menopausal Women

Abstract : The clinical trial to evaluate the estrogenic effects of the crude drug derived from dry powder of a phytoestrogen-rich Thai herb Pueraria mirifica (White Kwao Krua) under Tropical Herbal product in five female volunteers with menopausal symptoms showed that the crude drug clearly improved the signs and symptoms related to menopause such as, hot flushes, frustration, sleep disorder, skin dryness, high blood cholesterol, oligomenorrhoea and amenorrhea; with no change in the blood cells, liver and kidney functions, as well as other physiological status after four months of treatment In four volunteers, treatments were continued to complete a one-year test period with half the dose and was found to maintain their satisfied menopausal relief status. The crude drug dosage was administered at 200 mg daily for three weeks a month during the first four months of treatment and 200 mg every other day for 20 days per month for the remaining eight months. These doses were effective and safe as phytoestrogen treatment of menopausal symptoms.

INTRODUCTION
Menopause sometimes causes symptoms derived from decreased blood estrogen levels among middle-aged females. Estrogen Replacement Therapy (ERT) has been employed to protect and relieve symptoms but usually results in substantial cost and long-term treatment has a certain risk of estrogen-related cancer. Some recommendations such as lifestyle changes were proposed to minimize the menopausal symptoms. Dietary and other natural therapies, especially soy products which contain significant levels of phytoestrogens, namely isoflavones, were shown to be not only effective in eliminating certain menopausal symptoms, but also act as a potent anticancer therapy.

Pueraria mirifica (Airy Shaw et Suvatabandhu) or White Kwao Krua is a Thai indigenous herb with a long history of domestic consumption as a rejuvenating herb to promote youthfulness in both women and men. The herb was first brought to public attention in 1932 by a report that the tuberous root of the Kwao Krua herb found in the Northern Thailand contained active constituent with such rejuvenating property. That report elicited a study of the benefits of the herb and it was later proven in both animal experiment and clinical trial in a hospital by administering alcoholic crude extract of the herb. Such human benefit was also confirmed by another study. The herb was initially recognized as Butea superba, and was finally identified and clearly established as Pueraria mirifica.

Active ingredients were isolated and studied from the herbal tuber and was found to contain
miroestrol which exhibited the key estrogenic effect as reported from the studies in immature female mice and ovariectomized rat. A very interesting result was obtained from a clinical trial in nine female volunteers at the Chelsea Hospital for Women in London. U.K., who were suffering from amenorrhea, as well as one volunteer with artificial menopause.

The results clearly demonstrated that this active ingredient from P. mirifica could be administered as an estrogen supplement.

Other chemical constituents were also characterized including daidzin, daidzein, genistein, coumestrol, mirificin, genistin, puerarinand kwakhurin.

The phytochemical daidzin from soy source was known to prevent bone loss. Daidzein was reported to have immune enhancing activity, inhibitory action on induced lung metastasis and on specific mutagenicity.

Genistein was shown to have a negative result in Ames test for mutagenesis and act as a specific inhibitor of tyrosine kinase, an inhibitor of human breast cancer cell proliferation, as well as reducing bone loss. Coumestrol was shown to be an estrogen supplement and an anti-osteoporosis agent.
Stigmasterol was reported to have cholesterol lowering action.
B-Sitosterol was shown to reduce benign prostate hyperplasia and inhibit human
colon cancer growth, as were mirificoumestan and its derivatives. Recently, deoxymiroestrol, with stronger estrogenic effects than that ofmiroestrol was also isolated.

Thailand is the main natural habitat of Pueraria mirifica with a long history of consumption record. While soy is currently used for prevention and treatment of menopausal symptoms, this preliminary clinical trial with P. mirifica in Thai women could help evaluate its potential use for long-term phytoestrogen. supplementation and provide basic information to initiate a full-scale clinical trial. Such a trial could help us to clearly understand how the crude drug works in menopausal women

MATERIALS AND METHODS

1. Crude Drug Preparation

The fresh tuber of P. mirifica cultivar "Tropical-III” was collected, cleaned, peeled, sliced into pieces, dried in a hot air oven until nearly completely dried, ground into fine powder of 100 mesh size particles and finally filled into capsules with the net filling amount of 200 mg per capsule.

Isoflavone contents were analyzed by high performance liquid chromatography at Japan Food Research Laboratory, Osaka, Japan, from the powder with the aid of puerarin, daidzin, daidzein, genistin and genistein as references and subsequently used as active ingredient markers.

2. The Volunteers

Menopausal women with a history of cyst formation at the breast, uterus and / or ovary were excluded. Five accepted volunteers were the outpatients of Ramathibodi Hospital, Faculty of Medicine, Mahidol University, Bangkok, Thailand, with an age range from 35 to 52 years. These women suffered from oligomenorrhoea or amenorrhea, hot flushes, frustration, skin dryness, weakness and/or sleep disorder. The volunteers had complete blood cell count and blood chemistry analysis including hemoglobin, haematocrit, blood urea nitrogen, creatinine, SGOT, SGPT, cholesterol, triglycerides and urinalysis. The selected volunteers had to be in a normal health with normal blood chemical analysis results. They were verbally informed about the detail of the crude drug and the consumption of one 200 mg capsule a day for the first 21 days of the month for a 4 months period. If drug administration had to be extended, 1 capsule would be consumed every other day for the first 20 days of the month until the end of the 12th month. The volunteers had signed a written informed consent. Finally, 5 normal volunteers were recruited for the first 4 months trial period, whereas 4 volunteers were asked to complete the one-year test period.

3. Evaluation Criteria

3.1 Physical Examination Record

The body weight, height, breast, waist and hip sizes of the volunteers were recorded just prior to the test, as well as monthly when they came on appointment to receive a new capsule batch, and again at the end of the test.

3.2 Medical Interview

A medical doctor interviewed the volunteers with standard questions just prior to the test, as
well as monthly, and finally at the end of the test.

3.3 Total Blood Count and Blood Chemistry Analysis

Blood was collected for total blood count and blood chemistry analysis.
The results were analyzed just prior to the test, at the end of the 4th month test period, and at the end of the 12th month test period.

 
RESULTS

The results from the four-month and one year study from five selected volunteers are individually described as follows:-

Volunteer No. 1, 46 years old, weight 48 kg, height 1.47 m, had experienced amenorrhea period for 4 months with clear menopausal symptoms exhibited as hot flushes, frustration, sleep disorder and skin dryness. Physical examination as well as total blood count and blood chemistry analysis, were normal.

After completion of the 1st month test period, it was found that the patient's appetite increased, the body weight increased by 0.5 kg and recovered from hot flushes, frustration and skin dryness (especially facial skin).

After completion of the 2nd month test period, the patient had, recovered from sleep disorder. After completion of the 3rd month test period, all recovering symptoms were maintained.

After completion of the 4th month test period, the recorded menopausal symptoms showed remarkable recovering from the hot flushes, frustration, sleep disorder, and skin dryness. Total blood count and blood chemistry analysis revealed that the body responded to the crude drug normally, while the patient's recorded weight increased by 0.5 kg and no recurrence of menstruation period was observed. The volunteer was satisfied with the test results and stopped consumption of the crude drug at that time.

Volunteer No. 2, 52 years old, weight 47 kgs., height 1.47 m, had experienced amenorrhea period for 5 years with obvious menopausal symptoms as exemplified as hot flushes, frustration, sleep disorder and wrinkled facial and body skin. Her physical examination was normal. The total blood count and blood chemistry analysis were normal except blood cholesterol which was recorded as 247 mg%.

After completion of the 1st month test period, the facial skin had become firm while the body weight increased by 1 kg.

After completion of the 2nd month test period, full recovery from the sleep disorder symptom had occurred and her frustration had been abolished. The body weight increased by 3 kg. Her breasts were firm and showed a 2.5 cm increase in size. Two and a half cm increase in size of the waist and the hip had occurred.

After completion of the 3rd month test period, the skin was firm and hot flushes no longer occurred. Her total blood count was normal. The blood chemistry analysis showed a sharp decrease in blood cholesterol level from 247 to 205 mg% (17.0% decrease).

After completion of the 4th month test period, the patient showed full recovery from all recorded menopausal symptoms. The facial and body skin were firm and shiny. The net weight gain was 3 kg and recurrence of the menstruation was not observed.

The volunteer kept taking the crude drug until the end of 12th month. It was found that the previously recorded recovery from menopausal symptoms as well as the facial and body skin firmness were all maintained while the menstruation did not recur. The volunteer was satisfied with the test results.

Volunteer No. 3, aged 35 years old, weighed 62 kg, 1.66 m height. This patent had had amenorrhea for 7 months, was submitted to heart surgery (PDA ligation) 18 years ago, and also regularly suffered from constipation, sleep disorder, frustration, itching and a moderate amount of facial acne. Her total blood count and blood chemistry analysis were normal.

After completion of the 1st month test period, the breast size had increased by 2.5 cm and were firmed; her body skin became healthy and shiny; her facial acne disappeared resulting in clear face appearance.

After completion of the 2nd month test period, the recovered symptoms were maintained as recorded in the 1" month.

After completion of the 3rd month test period, the amenorrhea symptoms were fully disappeared as the volunteer exhibited menstruation period, itching was fully recovered, as well as sleep disorder and constipation. The body weight increased by 0.4 kg.

After completion of the 4th month test period, the menstruation period was recorded for 2 days, the body weight had increased by 1.5 kg, the breast size remained the same as that recorded before the test, but became firmer. The hip and waist circumferences had increased by 2.5 cm. Total blood count and blood chemistry analysis were normal.

The volunteer kept taking the crude drug until the end of 12th month. It was found that sleep disorder and frustrate symptoms were completely absent and the volunteer felt that she was in a good mood. Facial and body skin had recovered from dryness and retained firmness. The menstruation period was finally found to be irregular with increased volume. The final body weight increased by 2 kg. The volunteer was satisfied with the test results.

Volunteer No. 4, aged 49 years old, had had right ovariectomy. Her weight was 68 kg, and the height was 1.56 m. She had an irregular menstruation period, and thus, was classified as oligomenorrhoea. She had hot flushes and rheumatism, but her total blood count and blood chemistry analysis were normal.

After completion of the 1st month test period, the volunteer felt breast pain starting from the 3rd day. The result of breast examination revealed no abnormality in term of cyst formation.

After completion of the 2nd month test period, the menstruation period was found to be normal. The breast pain persisted but at a lower degree.

After completion of the 3rd month test period, the breast size had increased by 2.5 cm. She still had breast pain.

After completion of the 4th month test period, the skin became healthy and firm; backache remained; shorter menstruation period was found. Urinary problems such as mild dysuria occurred for some times. Laboratory results were normal.

The volunteer kept taking the crude drug until the end of one-year study period. Physical examination results were normal. The body weight was stable and the skin was healthy and firm. The regular menstruation period was maintained. The dysuria was investigated and white blood cells (6-10 cells / HPF) were found in urine. She was treated with ofloxacin for 7 days and the symptom was eliminated. The volunteer was satisfied with the test results.

Volunteer No. 5,39 years old, had a weight of 49.3 kg, a height of 1.58 m, and had been married for 12 years without having a baby. She had exhibited a fibro adenoma breast condition for 6 years. She was classified as oligomenorrhea due to the fact that the menstruation period had been reduced from 7 days to 3 days. She regularly had headache and frustration. The total blood count and blood chemistry analyses were normal except blood cholesterol level which was 237 mg%.

After completion of the 1st month test period, a fine acne had occurred on the face since the end of the 2nd week and thereafter developed into abundant acne for 1 week before completely disappeared. The menstruation period became normal with fresh color.

After completion of the 2nd month test period, the frustration had abated; the headaches had disappeared; the skin became healthy and firm; clear secretion was observed within the vagina; the breasts had increased by 2.5 cm in size and were firm while the waist and hip circumferences and the body weight remained the same.

After completion of the 3rd month test period, the menstruation period remained normal, as well as other parameters.

After completion of the 4th month test period, the menstruation period remained normal; the skin was healthy and firm; the body weight had increased by 1 kg. Total blood count and blood chemistry analysis were normal except blood cholesterol level which had decreased from 237 to 205 mg% (13.5% decrease).

The volunteer was asked to keep taking the crude drug until the end of the one-year study period. The normal menstruation period and the healthiness and firmness of the skin were fully maintained. The body weight had increased by 1 kg while the breasts were firm and had increased by 1 cm in size. The waist had also increased in size. The volunteer was satisfied with the test results.

The reported cases versus recovering cases in five menopausal women after 4 months consumption of P. mirifica crude drug are summarized in Table 1. The number of cases that exhibited adverse side effects is summarized in Table 2.

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Copyright © 2005 Sigma Pharma (M) Sdn Bhd. All rights reserved. Revised: May 07, 2007. Site Built by Simon.

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