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临床试验/CTRI/2024/07/071425
CTRI/2024/07/071425尚未招募3 期

A randomised controlled clinical trial to study the effect of darvi siddha tail in stanachuchuka vrana in sutikavastha with special reference to cracked nipples.

Dr Pooja Prabhakar Chougule1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Reduction in signs and symptoms of stanachuchuka vrana after application of darvi siddha tail

研究概览

简要总结

The prevalence rate of cracked nipple in breastfeeding during postpartum period is 32% .

In modern science treatment of cracked nipple is lanolin cream, corticosteroid creams which has its own side effects.

Use of these creams for long term causes thinning of skin, skin burning, stinging, irritation, baby’s mouth develops sores or redness.

In ayurvedic text convenient external medication like ghrita, tail applications are mentioned which are non invasive and effective.

Darvi siddha tail has properties like vranashodhaka and vranaropaka, drugs are easily available and cost effective and has more efficient properties to heal stanachuchuka vrana.Since no work has been done on Darvi Siddha Tail in stanachuchuka vrana i.e cracked nipples in sutikavastha and no comparative has been conducted out.So it will help to fill knowledge gap .

Including the married female patient having sign and symptoms of stanachuchuka vrana like stanachuchuka shula, rukshatva between age group of 18-35 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group). Darvi siddha tail for topical application to group A (Trial group), Nipcare ointment for topical application to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of tail preparation and drug application procedure will be followed throughout the clinical trial. Observation will be done on Oth and 7th day of treatment.

Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn, and thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out.

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 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • The signs and symptoms of stanachuchuka vrana like cracked nipple, nipple pain during breastfeeding, irritation of nipples, redness .
  • Postnatal mothers with the age of 18-35 years.

排除标准

  • Mastitis Breast abscess Congenital deformity like nipple inversion.

结局指标

主要结局

Reduction in signs and symptoms of stanachuchuka vrana after application of darvi siddha tail

时间窗: 7days

次要结局

  • When the trial group stands in comparison with control group(18 months)

研究者

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

Dr Pooja Prabhakar Chougule

SMBT Ayurved College and Hospital

研究点 (1)

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