A Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Mudgadya Ghrit Uttarbasti and Apamarg Kshar Taila Uttarbasti in the Management of Vataja Asrigdar w.s.r Adenomyosis
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Institute for Ayurved Studies and Research
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1 To improve the grading of Menorrhagia
概览
简要总结
PRIMARY PURPOSE IS TREATMENT
ADENOMYOSIS IS A CONDITION WHERE THERE IS A INGROWTH OF ENDOMETRIUM DIRECTLY INTO THE MYOMETRIUM. PREVALENCE OF ADENOMYOSIS IN CASE OF ENDOMETRIOSIS IS 70 PERCENT AND THE PREVALENCE IS FOUND TO BE 23.5 PERCENT IN PATIENTS WHO HAD COMPLAIN OF MENORRHAGIA 70 PERCENT FOLLOWED BY DYSMENORRHEA 30 PERCENT. THE PATIENTS ARE USUALLY PAROUS 90 PERCENT WITH ABOVE AGE 40. THE PATIENT WITH ADENOMYOSIS USUALLY PRESENT WITH MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA , INCREASE THE FREQUENCY OF MICTURITION AND INFERTILITY. IN MODERN MEDICINE, THE MAIN OBJECTIVE OF MANAGEMENT IS RELIEF FROM PAIN AND REDUCTION OF EXCESSIVE MENSTRUAL BLEEDING. MOSTLY USE NSAIDS AND HORMONAL THERAPIES AND LAST OPTION IS HYSTERECTOMY. HOWEVER LONG TERM USE OF THESE MEDICATIONS MAY LEAD TO ADVERSE EFFECTS ON WOMENS HEALTH. AYURVEDA AS A HOLISTIC SCIENCE AND WAY OF LIVING OFFERS PROMISING ALTERNATIVE TREATMENT MODALITIES THAT CAN POTENTIALLY REPLACE OR COMPLEMENT ALLOPATHIC APPROACHES WHILE MINIMIZING HARMFUL SIDE EFFECTS.
IN VIEW OF THIS EFFECT OF MUDGADYA GHRIT UTTARBASTI AND APAMARG KSHAR TAILA UTTARBASTI IN THE MANAGEMENT OF ADENOMYOSIS WSR VATAJA ASRIGDAR. THIS STUDY INVOLVES 40 PATIENTS. THESE 40 PATIENTS ARE DIAGNOSED WITH ADENOMYOSIS BASED ON CLINICAL EVALUATION AND SUPPORTING INVESTIGATIONS. MUDGADYA GHRITA AND APAMARG KSHAR TAILA ARE DIVIDED INTO 2 GROUPS . THIS WILL BE ADMINISTERED FOR 3 MONTHS IN FORM OF UTTARBASTI AFTER CESSATION OF MENSES AIMING TO RESOLVE THE SYMPTOMS OF ADENOMYOSIS SUCH AS MENORRHAGIA, DYSMENORRHEA AND OTHER SYMPTOMS RESOLVE MUSA CRITERIA FOR ADENOMYOSIS . OUTCOME MEASURE WILL INCLUDES BOTH SUBJECTIVE AND OBJECTIVE PARAMETERS. ALTHOUGH, ADENOMYOSIS IS NOT DIRECTLY CORRELATED WITH ANY DISEASE IN AYURVEDA BUT ON THE BASIS OF SYMPTOMS ADENOMYOSIS CAN BE CORRELATED WITH VATAJA ASRIGDAR. THIS STUDY AS TO PROVIDE AN EASY AND POTENTIALLY SAFER ALTERNATIVE TO CONVENTIONAL TREATMENT.
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
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Married female Patients of age between 21 to 50years 2 Patients willing to participate in Clinical Trial 3 Patient having Heamoglobin greater than 7gm percent 4 Patients having symptoms of AUB or frothy bleeding or Menorrhagia with one all the following symptoms such as dysmenorrhea dyspareunia and known case of Adenomyosis confirmed by any diagnostic technique 5 Patients are Yogya for Uttarbasti procedure.
排除标准
- •1 All pregnant women 2 Patients not willing for trial 3 Patient having Systemic Disease like Diabetes FBS greater than 125 mg per dl,Hypertension greater than 140 by 90mm of Hg,Severe Anemia Hb less than 7 gm percent 4 Patients having coagulation disorders, cardiovascular disorders, Cerebrovascular accidents 5 Patients suffering from Malignancy 6 Patient with congenital anamoly of reproductive tract 7 Acute inflammatory disease like Sexual Transmitted Disease like HIV, VDRL,HBsAg, HCV positive females 8 Patient Ayogya for Uttarbasti procedure.
结局指标
主要结局
1 To improve the grading of Menorrhagia
时间窗: Follow up will be done on 30,60,90,120 days
次要结局
- 1 Improvement in the Heamoglobin level(2 To resolve MUSA Criteria for Adenomyosis)
研究者
Dr Prajkta Gajanan Chaudhari
Institute for Ayurved Studies and Research