Two Arm, Randomized, Open Labelled, Comparative Clinical Study to assess the efficacy of Phalasarpi and Anuloma-Viloma Pranayama on the Maternal and Fetal Well Being during Pregnancy
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- full term normal vaginal delivery of a baby without any complications
研究概览
简要总结
Total 66 female participants in the age group of 21 – 35 years with positive Urine Pregnancy Test (UPT) and confirmed uterine gestation with USG irrespective of their parity will be screened according to inclusion and exclusion criteria of the study and included in the study after taking written informed consent. These participants will be explained the procedure provided the information of the patient’s to be confidential.
The participants in group A will consume Phalasarpi and perform Anuloma-Viloma Pranayama as follows:
The participants will be enrolled and come to the hospital most probably after 5 weeks and will be diagnosed as UPT positive. Also, this group will receive standard ANC care according to RCH-2 Program. Also, Phalasarpiwill be administered throughout the pregnancy. These participants will perform Anuloma-Viloma Pranayama.
The participants in group B will receive only standard ANC care according to RCH-2 program throughout the pregnancy.
· Objective Criteria: will bePregnancy completed weeks at the time of delivery, Type of Delivery, AFI at the end of 36 weeks, Birth weight of Child, APGAR score at 1 min. of birth, HB% of Mother at the time of delivery, Increase in Maternal weight throughout pregnancy, Foetal weight throughout the pregnancy
Specially designed Case Record Form (CRF) based on study protocol.
The study was completed with recruitment of total 66 females - 33 in each group. All female participants were followed till their delivery. No dropouts were there in the present study.
The data generated through clinical study was subjected to appropriate statistical tests to derive valid conclusions.
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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient with UPT positive and of age group 21 years to 35 years
- •Patient with UPT positive and confirmed uterine gestation with USG irrespective of their parity28
- •Patient with UPT positive confirmed uterine gestation with USG will be enrolled within 2 months of her LMP
- •UPT positive patient who is willing to consume Phala-Sarpiand performAnuloma-Viloma Pranayama.
排除标准
- •Patients with Pre-diagnosed underlaying pathology or a systemic disease.
- •Patients not willing to perform Garbhasanskara.
- •Patients with mental disorders like schizophrenia.
- •Patients of younger than 21 years and elder than 40 years of age.
- •Patients with any pre-existing tumour related to reproductive system.
- •Previous 2 LSCS.
结局指标
主要结局
full term normal vaginal delivery of a baby without any complications
时间窗: Baseline - before 8 weeks with UPT positive and confirmed uterine gestation with USG, 11th or 12th week of gestation, 18th or 19th weeks of gestation, 28th week of gestation, 32nd week of gestation,34th week of gestation,36th week of gestation, on the day of delivery of baby
次要结局
- Infections, Birth asphyxia and trauma, Preterm births and low birth weight and Congenital(malformations and others)
研究者
Dr Bhappil Sharma
Gangasheel Ayurvedic Medical College and Hospital, Kamua Kala Bareilly