A Randomised controlled clinical trial to evaluate the effect of Udumber Twak churna along with tandulodak in Asrugdara W.S.R. To Menorrhagia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1To study the effect of udumber twak churna with tandulodak in Asrugdara W.S.R. to Menorrhagia
研究概览
简要总结
Nature has gifted a woman with energy of procreation. In womens life menstruation is a natural physiological phenomenon.Menstruation is a natural process which starts with menarche and
ends with menopause. Menstruation and its abnormalities decides the womens general ,social and reproductive aspects of life.time Length of menstrual cycle is usually 21 to 35 days. Duration of
is 5 to 7 days and the blood loss ranging between 20 to 80ml.As per modern science menorrhagia is defined as regular Cyclic bleeding Which is excessive in amount (more than 80ml) or duration (more than 7days) or both is termed as Menorrhagia . Since there is excessive evacuation of Raja (menstrual
blood) that is Pradirana, the condition is termed as Pradara. Charaka say that increased amount of Rakta (blood) get mixed with Raja (menstrual blood), thus the quantity of Raja increases.As there is Dirana (excessive amount) of Asrik (menstrual blood) it is known as Asrugdara.Over the years, excessive and irregular uterine bleeding has become an increasingly frequent complaint.
So we have selected Udumber Twak Churna with tandulodak for oral administration in patient with heavy menses.
NEED OF STUDY
Complication that may occur due to lot of blood loss over time is severe Anaemia.It also disturbs mental health of women suffering from Asrugdar.Clinical study on this combination for management of Asrugdara is not conducted yet so it is also essential to verify the facts of drug described in bhavprakash.So our drug of choice has kaphapittashamak and raktastambhak properties which will ultimately correct the pathology of disease and helps in subsiding the symptoms.
NUMBER OF PATIENTS
Group A Study group 30 patients will be administered udumber twak churna along with tandulodak
Group B Control group 30 patients will be administered yashtimadhu churna along and Sita along with tandulodak
INVESTIGATION
CBC HIV HBSAG VDRL BT CT USG
Cbc will be estimated before and after treatment
SUMMARY AND CONCLUSION
The work will be summarized to make final conclusions Observations of results will be concluded
with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole
research.
EXPECTED OUTCOME
1 Changes in subjectives by udumber twak churns along with tandulodak towards reduction in previous severity.
2 Effect of udumber twak churna along with tandulodak could be more than the effect of yashtimadhu churna and Sita along with tandulodak without any adverse effects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Increase in number of bleeding days in the menstrual cycle (Bleeding more than 5 days ) 2 Decrease in intermenstrual period ( Period between two menstrual cycles less than 28 days ) 3 Quantitatively increase in menstrual bleeding ( no of pad 4 patient having hb 8 g per dl or less than 8 g per dl soakage per day that is more than 4 pad per day ) 5Patient having Hb 8g per dl or less than 8g per dl.
排除标准
- •1 Pregnant women 2Patient with post menopausal bleeding 3Endocrinological disorders like hypothyroidism and hyperthyroidism 4 Patient with traumatic bleeding or abortive bleeding 5 Patient diagnosed with neoplasm ( ca uterus , ca cervix) 6 Patient having congenital anomaly of genital tract 7 Any systemic disease like diabetes Mellitus , Hypertension,coagulation disorder , cardiac arrest , antepartum haemorrhage, PIH patients 8 Patient with tubo ovarian mass 9 Patient using any IUCD.
结局指标
主要结局
1To study the effect of udumber twak churna with tandulodak in Asrugdara W.S.R. to Menorrhagia
时间窗: 3 months
2 To evaluate the effect of drug on
时间窗: 3 months
a. Amount of blood loss
时间窗: 3 months
b. Duration of bleeding days in asrugdara
时间窗: 3 months
次要结局
- 1 To compare the effect of Udumber twak churna along with tanduloadak and yashtimadhu churna and Sita along with tandulodak in asrugdara(2 To collect the information about udumber twak and tanduloadak)
研究者
Dr Reshma Hanumant Kanade
R.A. Podar govt (Ayu) college Worli Mumbai