Clinical Study to Evaluate the Efficacy of Ayurveda Treatment Protocol in the Management of Garbhasayagata Arbuda WSR To Uterine Fibroid
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the size of uterine fibroid
研究概览
简要总结
PRIMARY PURPOSE:- TREATMENT
NEED OF STUDY:-Changing lifestyle in this era is leading to various disturbance in the normal physiological
phenomena and benign and malignant growths are getting lead off place nowadays. The incidence
of uterine fibroids accounted for 9.64 million globally in 2019, a significant increase compared
with the number in 1990 i.e 67.07% . The prevalence of it also rising up day by day leading
difficult situation for the female and the management of uterine fibroid are mostly invasive type
such as myomectomy, uterine artery embolization (UAE),Contraceptive pills,intrauterine devices
(IUD) and finally hysterectomy in modern science.
Where as Ayurveda system of medicine also have its own line of treatment which are very effective
and it also consists of surgical and parasurgical measures. And keeping this thing in mind and also to
propagate the knowledge of our great Acharyas some of common para-surgical measures such as
Siravedha and Panchakarma measures and Lekhana Basti,Uttar Basti and oral medication such as
Kanchanar gugulu which are less invasive had been selected for the study so that it could be
managed with few complications.
AIMS & OBJECTIVES-
AIM
To evaluate the efficacy of Ayurveda treatment protocol in management of Garbhasayagata
Arbuda.
Primary Objective
-
To study the Ayurveda literature on Garbhasayagata Arbuda
-
To evaluate the efficacy of Ayurveda treatment protocol to change in the size of
Garbhashyagata Arbuda.
Secondary Objective
To see the effect of trial drug and procedure on clinical features of the Garbhashyagata Arbuda.
RESEARCH QUESTION(S)
Research Question Is there any efficacy of Ayurveda treatment protocol in management of
Garbhasayagata Arbuda?
Hypothesis
H0: There is no efficacy of Ayurveda treatment protocol in management of
Garbhasayagata Arbuda.
HA: There is efficacy of Ayurveda treatment protocol in management of
Garbhasayagata Arbuda.
Trial Drugs and Procedure:
-
Siravedha
-
Lekhana Basti
-
Uttar Basti with Apamargakshar taila
-
Yoni Pichu with Apamargakshar taila
-
Oral medication i.e. Kanchanar gugulu
LABORATORY INVESTIGATIONS:
Before Treatment
-
CBC
-
Random Blood Sugar (RBS)
-
Liver function test (LFT)
-
Renal function test (RFT)
-
Clotting time (CT)
-
Bleeding time (BT)
-
Human Immuno-Deficiency Virus (HIV)
-
Venereal disease research laboratory (VDRL)
-
Hepatitis B surface Antigen (HbsAg),
-
Urine routine & microscopic
-
USG for Uterus and adnexa
During treatment: Hb % if needed
After Treatment:
-
CBC
-
RBS
-
Liver function test (LFT)
-
Renal function test (RFT)
-
USG for uterus and adnexa
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Having fibroid size upto 5 cm(confirmed by U.S.G)
- •Single or multiple fibroid
- •Female patient of age of 21-50
- •Only married females.
排除标准
- •Having any kind of malignancy.
- •Patient having bleeding due to abortion or any pathological condition.
- •Patients having coagulation disorders.
- •Patients having IUCDs in-situ.
- •Patient having fibroid larger than 5cm.
- •Pregnancy with fibroid.
- •Anaemic patient whose haemoglobin is below 10%.
结局指标
主要结局
Change in the size of uterine fibroid
时间窗: 90 days
次要结局
- Dysmenorrhea.(Menorrhagia)
研究者
Dr Roshika Pandey
National Institute Of Ayurveda,Deemed To Be University(De Novo),Jaipur, Rajsthan