A Randomized Comparative Study of Unani Formulations in Abnormal Uterine Bleeding due to Endometrial Hyperplasia
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Objectives: To compare the efficacy of polyherbal Unani formulations in heavy menstrual bleeding due to endometrial hyperplasia. Methodology: A prospective, randomized comparative trial was conducted at Govt. Nizamia Tibbi College. Group A (n=20) received Itrifal Aftimoon 5g orally BID from menstruation day 3 to day 21 plus suprapubic Marham Dakhilyun application and per vaginally Marham Dakhilyun (5g) and Roghan Gul (10ml) application from menstruation day 5 to day 14. Group B (n=20) received Gulnar Farsi (2g), Phitakri Biryan (0.25g), Dammul Aqwain (0.25g), and Geru (2g), 2.5g powder orally BID, menstruation day 3 for 20 days plus Douche Bargh Sambhalu then Ḥamūl of Safuf Mazu (2g), Kalijiri (2g) and Roghan Gul (10ml) from menstruation day 3 to day 12 for 3 consecutive cycles. The primary outcome was pelvic ultrasound findings of endometrial thickness. The secondary outcome measures were improvement in haemoglobin percentage, change in menstrual flow and menstrual pattern. The level of significance was 5%. Results and conclusion: The intragroup comparison showed that the mean endometrial thickness at baseline and after treatment in groups A and B was extremely significantly different (P<0.0001). The intragroup comparison showed the mean haemoglobin percent at baseline and after treatment in group, A was significantly different (P<0.0001). After treatment, 50% and 60% of participants had normal duration and menstrual blood loss after treatment from baseline in Groups A and B respectively. However, further, phase II and III randomized standard controlled trials in larger samples are recommended to assess the efficacy of these group medicines.
Abstract
Objectives: To compare the efficacy of polyherbal Unani formulations in heavy menstrual bleeding due to endometrial hyperplasia. Methodology: A prospective, randomized comparative trial was conducted at Govt. Nizamia Tibbi College. Group A (n=20) received Itrifal Aftimoon 5g orally BID from menstruation day 3 to day 21 plus suprapubic Marham Dakhilyun application and per vaginally Marham Dakhilyun (5g) and Roghan Gul (10ml) application from menstruation day 5 to day 14. Group B (n=20) received Gulnar Farsi (2g), Phitakri Biryan (0.25g), Dammul Aqwain (0.25g), and Geru (2g), 2.5g powder orally BID, menstruation day 3 for 20 days plus Douche Bargh Sambhalu then Ḥamūl of Safuf Mazu (2g), Kalijiri (2g) and Roghan Gul (10ml) from menstruation day 3 to day 12 for 3 consecutive cycles. The primary outcome was pelvic ultrasound findings of endometrial thickness. The secondary outcome measures were improvement in haemoglobin percentage, change in menstrual flow and menstrual pattern. The level of significance was 5%. Results and conclusion: The intragroup comparison showed that the mean endometrial thickness at baseline and after treatment in groups A and B was extremely significantly different (P<0.0001). The intragroup comparison showed the mean haemoglobin percent at baseline and after treatment in group, A was significantly different (P<0.0001). After treatment, 50% and 60% of participants had normal duration and menstrual blood loss after treatment from baseline in Groups A and B respectively. However, further, phase II and III randomized standard controlled trials in larger samples are recommended to assess the efficacy of these group medicines.
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