A Randomized comparative clinical study of prajasthapanamahakashaya granules and jeevaniyamahakashaya granules in prevention of garbhasrav (early pregnancy loss)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Continuation of Pregnancy, growth & development of fetus up to 20 weeks
研究概览
简要总结
Aims
To evaluate the clinical efficacy of Prajasthapana Mahakashaya granules and Jeevaniya Mahakashaya granules along with Vata Shunga Nasya in Prevention of Garbhasrava (Early pregnancy loss)
objectives •PRIMARY OBJECTIVE: To evaluate and compare clinical efficacy of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya Granules with Vata Shunga Nasya in prevention of Garbhasrava (Early pregnancy loss) SECONDARY OBJECTIVE: To evaluate the effect of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya granules with Vata Shunga Nasya on minor ailments of pregnancy.
| Hypothesis |
|NULL HYPOTHESIS(H0)
There is no difference in the efficacy of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya granules with Vata Shunga Nasya in prevention of Garbhasrava (Early Pregnancy Loss)
|ALTERNATIVE HYPOTHESIS(HA)
There is difference in the efficacy of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya granules with Vata Shunga Nasya in prevention of Garbhasrava (Early Pregnancy Loss)
GROUPING:
Group A : 40 patients will be treated by Prajasthapana Mahakashaya granules along with Vata
Shunga Nasya
Group B: 40 patients will be treated by Jeevaniya Mahakashaya granules with Vata Shunga
Nasya
DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY:
Total Duration of Trial: 2 Months
Follow up during treatment: At the Interval of 2 weeks up to 20 weeks of Pregnancy
Follow up after treatment: 1 month
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married female 21-40 years age group with positive urine pregnancy test will be taken into study between 4-10 weeks of pregnancy with having history of any following conditions: One or more spontaneous abortion Elderly primigravida Pregnancy after Infertility H/O Intra Uterine fetal death Previous preterm birth Choriodecidual haemorrhage in present pregnancy.
排除标准
- •Patient with severe systemic disease like cardiovascular complications, uncontrolled diabetes mellitus, hematological disorders, hyperthyroidism, Urinary tract infection etc.
- •Pregnancy with carcinoma, large ovarian cyst, large uterine fibroid, uterine prolapse.
- •Pregnancy with history of incompetent OS & congenital uterine malformations.
- •Pregnant female with history of previous congenital malformed child.
- •Sexually transmitted diseases like VDRL, HIV, HbsAg and HCV will be excluded.
- •Pregnancy with TORCH IgM Positive Cases.
结局指标
主要结局
Continuation of Pregnancy, growth & development of fetus up to 20 weeks
时间窗: 2 months
次要结局
- Changes in the minor ailments of pregnancy.
研究者
Dr Anjali Jain
National Institute of Ayurveda(De Novo) Jaipur