跳至主要内容
临床试验/CTRI/2026/01/101279
CTRI/2026/01/101279尚未招募2/3 期

A randomized open labelled comparative clinical study to evaluate the efficacy of bhadrotkatadya avaleha and panchakola churna in the management of sutika sula

Shree Swaminarayan Ayurvedic College, Kalol1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月27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
40
试验地点
1

研究概览

简要总结

Sutika sula, particularly postpartum back pain (prstha Kati Sula), is a common condition in the puerperal period caused by Vata aggravation and tissue depletion, which affects mobility, sleep, and breastfeeding comfort, while modern management focuses mainly on analgesics and antibiotics, it does not address digestive weakness or systemic nourishment, creating a clinical evidence gap in Ayurveda regarding formulation based comparative pain management in lactating mothers, so this randomized open label parallel arm study will evaluate 40 postpartum women delivered vaginally within 7 days, comparing Bhadrotkatadya Avaleha (12 g BID with warm milk) and Panchakola Churna (6 g BID with warm water) for 60 days, using standardized pain assessment through VAS and a modified symptom score based on the Brief Pain Inventory framework, along with evaluation of associated symptoms like abdominal distension, constipation, appetite, formulation compliance, palatability, and safety monitoring for both mother and infant, with anticipated outcomes of significant pain reduction and better postpartum recovery, contributing to evidence based Ayurvedic postpartum care protocols.

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

  • 1.Women aged 18–40 years who have delivered within 7 days (vaginal delivery primi & multi) 2.Presenting with symptoms as per diagnostic criteria 3.Willing to participate and comply with follow-up for 60 days 4.Capable of providing written informed consent.

排除标准

  • 1.Age below 18 years or above 40 years 2.Cesarean delivery, instrumental delivery, or manual removal of placenta 3.Spinal conditions Pott’s spine (TB spine),Spinal cord compression,History of trauma or surgery to spine/lower back 4.Rheumatoid arthritis, ankylosing spondylitis, or other systemic musculoskeletal disorders 5.Severe anemia (Hb less than 8gm percent) or postpartum hemorrhage (PPH) 6.Back pain due to structural disc prolapse, vertebral fracture, or known neurological condition 7.Patients with uncontrolled diabetes.

研究者

发起方
Shree Swaminarayan Ayurvedic College, Kalol
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vaibhavi Shripati

Shree Swaminarayan Ayurvedic college and hospital Kalol

研究点 (1)

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