A Comparative Clinical trial to evaluate the efficacy of Lekhaniya Mahakashaya based Ghanvati and Siddha Taila Uttarbasti in the management of Garbhashayagata Arbuda with special reference to Uterine Fibroid.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a Randomised, comparative clinical study Phase 2 Parallel group trial. Comparing the efficacy of Lekhaniya Mahakashaya based Ghanvati and Siddha Taila Uttarbasti in the management of Garbhashayagata Arbuda with special reference to Uterine Fibroid for 3 months in 40 patients. The patient fulfilling the clinical criteria for diagnosis of Garbhashayagata Arbuda will be randomly selected from OPD/IPD of state Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group-A- In this group patients will be treated with Lekhaniya Mahakashaya based Ghanvati orally 2 Ghanvati BD Pragbhukata with Ushnodaka Anupana for the period of 3 months. Group-B- In this group patients will be treated with Lekhaniya Mahakashaya based Ghanvati orally 2 Ghanvati BD Pragbhukata with Ushnodaka Anupana for the period of 3 months along with Lekhaniya Mahakashaya Siddha Taila Uttarbasti of 3-5 ml by intra-uterine route for the period of 3 days for 3 consecutive cycles after the clearance of menses. Follow up period will be 30 days after the completion of trial.
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
- 22.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married female of age group between 22 to 45 years
- •Patients having Fibroid size less than or equal to 5 centimeter as per USG report with or without associated symptoms
- •Single or multiple Fibroids upto 3
- •Patients willing to participate and giving informed consent.
排除标准
- •Married female below the age of 22 and above the age of 45 years
- •Patient having Fibroid size more than 5cm and number of Fibroids more than 3 as per USG report
- •Patients having Submucosal Fibroids
- •Pregnant women and lactating mothers
- •Patient coming with Hb less than 9 gm per dl
- •Patient using intra-uterine contraceptive device or taking OCPs
- •Patient suffering from any other pelvic pathology like Ovarian tumour, Tubo ovarian mass, Endometriosis, PID, Malignancy, Cervical Polyp etc
- •Patient suffering from any systemic illness like Hypertension, Tuberculosis, Cardiac disorders, etc
- •Patients with acute and chronic inflammatory disease eg- UTI, HIV, HBsAg, VDRL, HCV etc.
研究者
Dr Vertika Chaturvedi
State Ayurvedic College and Hospital, Lucknow Uttar Pradesh