Clinical Studies On Furocyst

EVALUATING THE PERFORMANCE OF FUROCYST IN 370 PATIENTS WITH POLY CYSTIC OVARY SYNDROME, PGIMER, CHANDIGARH

Efficacy conclusions

Number Of Cysts- The number of cysts decreased significantly in both left (38.2%) and right ovaries (37.28%) on completion of the treatment with Furocyst, whereas in placebo group number of Cysts increased significantly in both left & right ovaries. In Furocyst group, 80% of the patients showed decrease in number of cysts in right ovary and 70.59% of the patients showed decrease in number of cysts in left ovary.

Ovary Volume- The ovary volume decreased significantly in both left (40.12%) and right ovaries (33.05% ) on completion of the treatment with Furocyst, whereas in placebo group ovary volume increased significantly in both left & right ovaries. In Furocyst group, 83.33% of the patients showed decrease in right ovary volume and 73.26 % of the patients showed decrease in number of cysts in left ovary.

Hirsutism Score- There was 27.06% decrease in Hirsutism score in Furocyst treated group, whereas there was a considerable increase in Hirsutism score in placebo treated group. In Furocyst 67.68% of study population showed improvement in Hirsutism score.

Pregnancies – In Furocyst group, total 34 Females got pregnant, 30 during the study and 4 after the completion of treatment.

Prolactin Levels, Free testosterone, LH and FSH level- A significant decrease was observed in Prolactin Hormone levels, free testosterone, LH and FSH Levels with respect to its baseline value on completion of treatment with Furocyst whereas significant increase in Prolactin hormone was observed in placebo group, with no significant change in free testosterone level, LH and FSH level as compared to respective baselines value.

Menstrual Cycle- Furocyst group showed improvement and regularization of menstrual cycle as compared to placebo group. At the baseline, 55% of the study population in Furocyst group showed irregular cycle and 53.6 % of the study population in placebo group showed irregular cycle. The percentage of patients reported irregular menstrual cycle on treatment with Furocyst was reduced significantly and only 13.75% patients reported irregular cycle in the Furocyst group. There was not much improvement in periodicity of menstrual cycle in placebo group. 43.29% of patients still reported irregular cycle at the end of the study treatment. In Furocyst group, 91.25% of the study population showed improvement in menstrual cycle.

Safety conclusions

Liver Function Test (LFT): No abnormal change in Serum GOT and Serum Alkaline phosphatase activities was observedon treatment with Furocyst and placebo on completion of the respective treatments.

Renal Function test (RFT): No abnormal change in Serum urea and Serum creatinine levels were observed on treatment with Furocyst and placebo on completion of the respective treatments.

Hemogram: No abnormal alteration in hematological parameters were observed on treatment with Furocyst and placebo on completion of the respective treatments.

Lipid profile: There was significant decrease in lipid parameters including cholesterol levels, LDL cholesterol and triglyceride levels of the study population in Furocyst treated patients on completion of the treatment whereas there was no significant alteration in lipid parameters of placebo group.

Study of FUROCYST in 107 polycystic ovary syndrome(PCOS) patients at King George’s Medical University, Lucknow, U.P.

Efficacy conclusions

Ovary volume: The left ovary volume of the study population was significantly decreased up to 23.78% till the completion of the treatment (p-value 0.0001**). Similarly, right ovary volume was also reduced significantly up to 29.32% till the completion of the treatment (p-value 0.0001**). The left ovary volume was decreased in 90% of the patients and right ovary volume was decreased in 96.7% of subjects.
Cyst size: The mean cyst size in the right ovary of the study population was significantly reduced up to 41.57% till the completion of the treatment (p-value 0.0001**). If we consider cyst size of the left ovaries, it was also decreased significantly up to 44.92% in the study population till completion of the treatment (0.0001**). Fifteen patients got pregnant during the study & complete dissolution of cysts was observed in 8 patients.
HOMA index: Being a major indicator of insulin resistance, HOMA index was also shown to be significantly reduced up to 46.54% in 75.67% of the study population till the completion of the treatment (p-value 0.0001**).
Menstrual cycle: Menstrual cycle of the study population was regularized in most of the patients. Only 1.1% of study population had regular menstrual cycle at baseline and after 12 weeks of treatment with Furocyst, 79.5% of the study population had regular menstrual cycle.
Prolactin levels: Mean Prolactin levels were significantly decreased on completion of treatment.

Safety conclusions

Liver Function Test (LFT): There was no significant change in liver function test of the study population except ALT/SGPT activity which were slightly decreased (p-value 0.007**) but remained under normal range on the completion of the treatment.
Renal function test (RFT): There was non-significant change in urea levels but creatinine levels changed significantly on the completion of the treatment (p-value 0.032*) but remained under normal range.
Hemogram: There was non-significant change in hemoglobin levels and differential leukocyte count (DLC) of the study population on the completion of the treatment. Total leukocyte count (TLC) of the study population decreased slightly on the completion of the treatment (p-value 0.002**).
Lipid profile: There was non-significant change in lipid profile including cholesterol levels and triglyceride levels of the study population whereas HDL levels of the study population increased significantly on completion of the treatment (p-value 0.030*).

Post marketing surveillance study of fenugreek seed extract in 50 polycystic ovary syndrome patients

Efficacy conclusions

1. Fenugreek seed extract caused a significant reduction in the ovary volume.

2. 46% of the study population showed a reduction in cyst size.

3. 36% of the study population showed complete dissolution of the cysts.

4. 12% of the patients got pregnant.

5. 71% of the patients reported regular menstrual cycle on completion of the treatment.

6. Overall 94% of the patients reported positively or got benefitted from the fenugreek extract dosing.

Safety conclusions

1. Keeping hematological and biochemical results in view, investigational product was safe for consumption.

2. No significant change in liver function tests was observed.

3. No significant change in renal function tests was observed.

Clinical Studies On Furocyst

Clinical Studies On Furocyst

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