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Home > Assessment of Various Feminine Disorders in Pcos by a Polyherbal Formulation

Assessment of Various Feminine Disorders in Pcos by a Polyherbal Formulation

Thesis Info

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Author

Ishaque, Sumaira

Program

PhD

Institute

University of Karachi

City

Karachi

Province

Sindh

Country

Pakistan

Thesis Completing Year

2016

Thesis Completion Status

Completed

Subject

Pharmacognosy

Language

English

Link

http://prr.hec.gov.pk/jspui/bitstream/123456789/14012/1/Sumaira_Ishaque_Pharmacognosy_2016_UoK_Karachi.pdf

Added

2021-02-17 19:49:13

Modified

2024-03-24 20:25:49

ARI ID

1676725549458

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This research work is based on the clinical assessment of polyherbal formulation, Femitex-SP4, used for treating different feminine disorders in PCOS. It is basically the combination of four medicinal plants which are known to have rich medicinal phytocomponents with remarkable therapeutic potential. The herbs used are; Plant-A, Saraca indica L. (bark); Plant-B, Vitex agnus castus L. (fruit); Plant-C, Embelica officinalis L. (fruit); Plant-D, Symplocos racemosa Roxb. (bark). Although extensive work has been done on these plants regarding their efficacy in different ailment especially female disorders; there is no exclusive findings available in previous 100 years literature regarding the use of these four plants in combination. We had attempted the study for the first time, when we clinically evaluated the efficacy of Femitex-SP4 in Menorrhagial women and found great results in previous research. PCOS is a diversified hormonal disorder often resulting in infertility and countless health problems. It is believed that primarily PCOS is transmitted through genes and currently it is not completely curable. In dealing with different aspects of PCOS, role of phytoestrogenic medicinal herb is very important and the herbs used in the formulation of Femitex-SP4 have considerable phytoestrogenic activity and a powerful antioxidant potential. Prior to conduct clinical trial on the formulation, Femitex-SP4, Pharmacognostic and photochemical studies were carried out on each herb (A-D), separately and along with formulation too; to establish the quality, safety and efficacy of Femitex-SP4 through standardization according to WHO guidelines. After this exercise, the phytopharmaceutical evaluation, formulation (250 mg powdered capsule) and stability studies (in different intensities of light, temperature and humidity) were performed according to the B.P standards. Along with it we also aimed our research towards performing toxicological studies (i.e. Brine shrimp lethality Bioassay, insecticidal activity and phytotoxicity) of our formulation, Femitex-SP4 and it was found to be safe for human consumption. Besides these, we also got ethical approval to conduct our study from Independent Ethics Committee (ICCBS), university of Karachi. To achieve our overall aim we conducted our research in two parts. In phase one, we performed a comparative analysis of PCOS and Non-PCOS women; clinical findings of about 50 PCOS and 50 Non-PCOS patients were evaluated on the basis of general patient inquiries filled by patient in the questionnaire provided to them, as well as on the difference in overall morphology of ovary; as seen in the ultra-sonographic reports. Not a major difference was found in the demographic profile, general health, educational level and socio-economic status among PCOS and Non-PCOS women. But a significant difference (i.e. * P = 0.05) was observed in obesity level, menstrual and reproductive history, and ultra-sonographic reports of PCOS women when compared to Non-PCOS women. Also after phase one, PCOS parameters on which Femitex-SP4 has to be evaluated were set (i.e. Acne, Hirsutism, Oligo/amenorrhea, and Infertility). In phase two, we conducted a single blind randomized placebo controlled clinical trial of Femitex-SP4, by placing 150 patient in active group and 125 in placebo after screening. Women in between 18-44 years of age were recruited in phase two, and majority of them (105/150) were between 21-35 years of age; which shows that women effected most by PCOS in their peak reproductive years. The incidence of PCOS among married and unmarried women found to be almost equal, i.e. single women (52%) and married (48%). The Quality of Life (QoL) of PCOS women were also evaluated by their emotional health screening through a questionnaire. Anxiety (mood swings, fatigue), depression (nervousness, tension), and emotional Distress (mood swings, poor self-esteem); were the most reported signs effecting QoL of the women before they undergone the clinical trial. In phase two, firstly 100 active and 100 placebo women were compared; women in active group shown substantial after treatments results both physically and psychologically. An improvement of about 39% in anxiety, 67% in depression, and 72% in emotional distress have been shown by active group whereas placebo group has shown only 1 to 2% improvement in psychological symptoms. Physically women in active group shown on average about 50% improvement in the defined symptoms, but placebo group revealed only 1% improvement. Secondly in phase two, those 150 patients enrolled in the active group were dropped into six separate groups according to the existence and severity of their symptoms; in order to further evaluate the obtained results as per no of treatment they required to show decline in symptoms. The findings of this study will add in some ways towards the demonstrational efficiency of polyherbal drug, Femitex-SP4 for PCOS symptoms, as it contain such important chemical constituents that have significant antioxidant, hormonal, and hemostat potential. And they are not only used for curifying a diseased state but they are also very good dietary supplements, which enhance and boost total body immune system. As no adverse effect reported during the entire course of the research, the use of polyherbal medicine as an ultimate substitute of modern conventional medicine for PCOS can be recommended.
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