A randomized open labelled controlled clinical study to evaluate the efficacy of Haritakyadi Yoga in the management of Garbhini vibandha W.S.R constipation during pregnancy.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Trial drug will help in management of constipation during pregnancy
研究概览
简要总结
Vibandha is not described as a separate disease in our Samhitas. It is described under symptoms of many diseases like Ajeerna, Samadosha, Koshthaashrita vata, Gudagata vata, Pakwasyagata vata.
The term Vibandha is mentioned with different context to Pureesha like Malasanga, Viddgraha, Vishtambha, Malabadhata, Stabhapureeshata. It occurs due to Vikruti of Apana vata and the Srotas involved is Pureeshavaha Srotas.
Gastrointestinal disorders are frequently experienced during pregnancy. As far as gastrointestinal complaints go, constipation is the most frequent, second after to nausea. During pregnancy upto 40% of women experience constipation symptoms at some point.
The word Constipation comes from Latin word ‘Constipare’ which means – To press or crowd together. It refers to persistent,difficult, infrequent or seemingly incomplete defecation.
It is defined as infrequent passage of hard stool. Patient may also complain of straining, a sensation of incomplete evacuation and either perineal or abdominal discomfort.
It is a symptom, not an illness.
Constipation is quite common ailment during Pregnancy. Atonicity of the gut due to effect of Progesterone, diminished physical activity and pressure of the gravid uterus on the pelvic colon are the possible explanations.Emotional disturbances, Iron supplements, disturbed sleep are the other causes which leads to Constipation. Suppression of defecation urge is also a very important cause of Constipation.
It may cause backache and abdominal discomfort. Regular bowel movements may be facilitated by regulation of diet by taking plenty of fluids, vegetables and milk or prescribing stool softners at bed time. There may be rectal bleeding, painful fissures or haemorrhoids due to hard stool.
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
- •1 Patients having confirm diagnosis of pregnancy.
- •2 Patients presenting the classical symptoms of Garbhini Vibandha.
- •3 All patient diagnosed with Vibandha during 2nd and 3rd trimester of pregnancy (both primigravida and multigravida).
- •4 Patients who are willing to sign consent form and participate in clinical trial.
排除标准
- •1 Age less than 21 and more than 35 years.
- •2 Patients of 1st trimester of pregnancy.
- •3 Patients who are not fulfilling the inclusion criteria.
- •5 Vibandha caused due to any medical and surgical condition.
- •6 Patient with PIH (Pregnancy induced hypertension)and GDM (Gestational Diabetes Mellitus) and High-risk pregnancies (Molar pregnancy and Ectopic pregnancy).
结局指标
主要结局
Trial drug will help in management of constipation during pregnancy
时间窗: follow up on 3rd day 7th day 15th day and 21st day
次要结局
- Trial drug will help to manage other associated symptoms(follow up on 3rd day 7th day 15th day & 21st day)
研究者
Dr Monika
Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118
