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临床试验/CTRI/2024/12/077657
CTRI/2024/12/077657尚未招募2/3 期

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.

Dr Monika1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月1日最近更新:

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

发起方
Dr Monika
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Monika

Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118

研究点 (1)

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