EFFICACY OF VIRECHANA KARMA, DASHAMOOLA TRIVRUTA TAILA MATRA BASTI AND GUDUCHYADI KASHAYA ORALLY IN THE MANAGEMENT OF ENDOMETRIOSIS - A SINGLE ARM OPEN LABELLED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- (a)
研究概览
简要总结
Introduction:
Endometriosis is defined as the presence of endometrial tissue (glands and stroma) outside the uterine cavity. It is benign but it is locally invasive, disseminates widely. Dysmenorrhea (Menstrual cramps), dyspareunia (painful intercourse), dyschezia (Obstructed defecation), dysuria (Discomfort urinating), pelvic pain and infertility are the prominent symptoms seen in women suffering from endometriosis.
Ayurveda explains that it is not always possible to name a disease in a definite term. endometriosis is not an exception for the same. Hence this disease has to be analyzed according to the Nidana Panchaka theory of Ayurveda based on the concepts of Dosha, Dushya, Srotas, Samprapti, and its management. The general treatment principles can be laid down by going through the treatment principles of Artavadushti, Pradara, Yonivyapad, Raktapitta, Gulma and Granthi. All these principles can be summarized as Shodhana therapy for Srotoshodhana and Shaman therapy as Vatanulomana and Lekhana.
Why this topic:
There is no such effective treatment in modern science other than hormonal therapy and surgery. Hormonal therapy has its own side effects and it is not a ‘complete cure’. Laparoscopy or surgical management is not opted by most of patients due to side effects and high cost of the treatment. Keeping all this views in mind, a better, safer
and effective therapy is needed for the present society which not only resolves the chocolate cyst, but also improves related menstrual problem and enhance the normal functioning of reproductive system. Looking into the etiopathogenesis and complications of endometriosis, it requires a systemic therapy for which Ayurveda may provide a hope through Shodhana and Shamana treatment. Thus, Present study has been planned to evaluate therapeutic efficacy of VIRECHANA KARMA, DASHAMOOLA TRIVRUTA TAILA MATRA**BASTI AND GUDUCHYADI KASHAYA ORALLYin the management of endometriosis.
Aims and Objectives:
AIM
To evaluate the efficacy of Virechana followed by Dashamoola Trivruta Taila Matra Basti and Guduchyadi Kashaya orally in the management of Endometriosis.
OBJECTIVES
1. To assess the efficacy of the treatment protocol in VAS score of dysmenorrhea, dyspareunia and deep-seated pelvic pain.
2. To evaluate the quality of life by using EHP-30 questionnaire.
Materials and Methods:
In the present study total minimum 15 diagnosed patients of endometriosis based on USG parameters, fulfilling the selection criteria will be registered. Single group of the patients will be treated with Virechna Karma followed byDashamoola Trivruta Taila Matra Basti and Guduchyadi Kashaya Orally.
Duration of study:
3 months along with 1 month of follow up.
Follow up:
After completion of therapy, follow up will be done for 1 month to assess the status of patient, where patient will be asked to report.
Side Effects:
These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
Results and Discussion:
Data generated during the above study will be presented in a systemic manner as shall be analysed and the section where the important points of the Conceptual study, Clinical study, Pharmacological study will be discussed.
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
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •Both married and unmarried females of above age group Patients having clinical signs and symptoms of endometriosis Already known case of Endometriosis Patients having CA-125 level less than 500U/ML Patients having chocolate cyst size less than 7cm Patients eligible for Virechana Karma and Basti Patients willing to participate in trial.
排除标准
- •Patients having age less than 18years and more than 50year Patients having chocolate cyst size more than 7cm Patients having CA-125 level more than 500U/ML Patients having endometriosis of sites other than pelvis and scar endometriosis. Known case of Carcinoma, Congenital anomaly or infectious diseases of reproductive tract like Tuberculosis, STDs, etc. Patients with history of cardiac diseases, chronic liver disease, uncontrolled hypertension (Systolic BP above 160 & Diastolic above 100 mmHg), uncontrolled diabetes mellitus (above the range of 160 mg/dl.
- •RBS) Patients not eligible for Virechana Karma and Basti and not willing to participate in trial.
结局指标
主要结局
(a)
时间窗: During the treatment period of 4 months
Improvement in clinical features of Endometriosis
时间窗: During the treatment period of 4 months
(b)Improvement in Quality of life.
时间窗: During the treatment period of 4 months
次要结局
- (a) Reduction in the size of Endometriosis.(After the treatment period of 4 months)
研究者
Priyanka Eknath Pradhan
Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat
