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临床试验/CTRI/2017/02/007969
CTRI/2017/02/007969招募中3 期

Management of First trimester Pregnancy with Rasayana and Nasya and Micronized progesterone A Randomized controlled clinical trial

INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVED GUJARAT AYURVED UNIVERSITY JAMNAGAR1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月2日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
continue the first trimester of pregnancy without any risk

研究概览

简要总结

During 1st trimester of pregnancy fetus is craving for food as mother is unable to intake due to nausea and vomiting So there may be a chance of nutritional deficiency to the fetus ultimately results in miscarriages During the embryonic stage before formation of solid dhatu fetus gets the nutrition through osmosis and from peripheral capillaries In Ayurveda  Rasayana therapy defined as a rejuvenating agent for promotion of health and cure of the diseases in all stages of life According to Harita Rasayana promotes strength to the body and Indriyas Here use of Rasayana act as a supportive for pregnancy fetal development and proper organogenesis during embryonic stageThe best time for administration of Rasayana Purve Vayasi Madhye va**Here 1st trimester has beenconsidered as purvevayaHere Nasya is to be used for effective Garbhasthapaka Aushadha instilled through nostril directly stimulate the Sringataka marma for balancing of all the Indriyas, Srotas and doshasSome specially mentioned drugs when administered properly acts as effective Garbhasthapaka  in conjugation with upgrading the qualities of fetus In Sushruta Samhita Dalhana Acharya has mentioned above Nasya for Garbha Grahanaaya Garbha Sthapanaartham and Putra Apathya JananaarthamVagbhatacharya in Ashtanga Sangraha quoted the same

Group A Rasayan granules 10 gm bd in empty stomach after urine pregnancy test positive continuing for 6 weeks throughout the first trimester and  8 vatashrunga triturated with milk nasal instillation either right or left 3 or 4 drops for 3 cocecutive days after urine pregnancy test positive

Group B Rasayan granules 10 gm bd in empty stomach after urine pregnancy test positive continuing for 6 weeks throughout the first trimester

Group C micronised progesterone tab 200 mg bd for 6 weeks after urine pregnancy test positive throughout the first trimester

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • pregnant ladies just after UPT test positive starting from 6 weeks upto 12 completed weeks and also the same above with any of the following conditions bad obstetric hstory elderly primi delayed foetal pole development choriodecidual hemorrhage.

排除标准

  • women below 18 years and above 35 years pregnancy with systemic cardiac hematological neurological autoimmune endocrinal renal hepatic thyroid disorders Diabetes Mellitus Reproductive tract Ca Pelvic Inflammatory Disorders Sex Transmitting Disorders TORCH and VDRL positive.

结局指标

主要结局

continue the first trimester of pregnancy without any risk

时间窗: 6 weeks

improve the maternal and foetal wellbeing

时间窗: 6 weeks

次要结局

  • compare the effect of Rasayana granules vatashrunga nasya and micronised progesterone in continuing the pregnancy and minimising complications and discomforts in first trimester(6 weeks)

研究者

发起方
INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVED GUJARAT AYURVED UNIVERSITY JAMNAGAR
申办方类型
Research institution and hospital

研究点 (1)

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