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临床试验/CTRI/2025/03/081718
CTRI/2025/03/081718尚未招募3 期

EFFECT OF KUSHMANDA GRANULES IN THE MANAGEMENT OF GARBHODAKA KSHAYA W.S.R TO OLIGOHYDRAMNIOS- A RANDOMIZED OPEN LABELLED STANDARD CONTROLLED CLINICAL TRIAL

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月10日最近更新:

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

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mamta Kumari

Institue of Teaching and Research in ayurveda,INI, Jamnagar

研究点 (1)

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