EFFECT OF KUSHMANDA GRANULES IN THE MANAGEMENT OF GARBHODAKA KSHAYA W.S.R TO OLIGOHYDRAMNIOS- A RANDOMIZED OPEN LABELLED STANDARD CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Increment of AFI.
研究概览
简要总结
Information on the Trial procedure and Drug: Here in Group A- Kushmanda Granules 5 gm orally twice a day with milk for 15 days*.* In Group B- L- arginine sachet 10gm in divided doses orally with water. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.
**Description of the Process:**In present study, participants who will be clinically diagnosed and confirmed cases of Garbhodaka Kshaya (Oligohydramnios) enlisted in inclusion criteria will be enrolled. All patients will be divided into two groups by computer generated randomisation technique, having minimum of 10 patients in one group. Group A will be given with Kushmanda Granules 5 gm orally twice a day with milk for 15 days. And Group B will be given with L- arginine sachet 10gm in divided doses orally with water
Follow-up: Patients will be advised to visit the hospital every 5th day during the treatment for
15 days and then after7 days after treatment as a follow up.
Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects.
Results: The efficacy of the therapy will be assessed on the basis of subjective and objective criteria.
Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Garbhodaka Kshaya (Oligohydramnios). Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect
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
- 18.00 Day(s) 至 40.00 Day(s)(—)
- 性别
- Female
入选标准
- •Pregnant women with equals to or more than 24 and equals to or less than 36 weeks Period of Gestation,Singleton pregnancy,Membrane should be intact,Patients with Amniotic fluid index equals to more than 4 or equals to or less than 8, Both primi gravida and multigravida.
排除标准
- •Multiple pregnancies,Premature rupture of membrane,Pregnant women with HIV, HbsAg, VDRL, HCV positive, known case of Diabetes mellitus or diagnosed with Gestational Diabetes.
结局指标
主要结局
Increment of AFI.
时间窗: During the treatment period of 15 days
次要结局
- Change in Maternal weight, Foetal weight(Change in pregnancy associated physiological hindrances such as Daurbalya, Angamarda, Aruchi, Malabaddhata, Udarashoola, Katishoola, Padashoola, Anidra)
研究者
Mamta Kumari
Institue of Teaching and Research in ayurveda,INI, Jamnagar
