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临床试验/CTRI/2024/06/069640
CTRI/2024/06/069640尚未招募2/3 期

An Exploratory Study to evaluate the effect of Nabhi Puran(Navel Oiling) with Erandmool Siddha Tail in PMS (Premenstrual Syndrome) in order to restore Normal Physiology

Priyanka Rajkumar Bhosale1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2024年7月8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
95
试验地点
1
主要终点
change in severity of symptoms

研究概览

简要总结

Menstrual history will be taken from volunteers like previous date of 1st day of menses and days of flow and number of pads used and symptoms according to PMSS Questionnaire. Volunteers in which 1 somatic and 1 behavioural symptom present for atleast 2 menstrual cycles in a row  according to Premenstrual syndrome scale will be enrolled in study.  Date of Ovulation day will be calculated . Erandmool Siddha Tail is to be given to volunteers to be used for Navel oiling from the day of ovulation to the 1st day of menses that is for 14 to 18 days. Procedure should be done by volunteers itself. It should be done empty stomach at evening  or  2 hours after dinner before sleep. Volunteers will be asked to massage over stomach in clockwise direction in 200 rotations by taking 7 to 8 drops of luke warm erandmool siddha tail or oil in navel and rest in supine position for atleast 15 to 20 minutes. Any change in symptoms from day of ovulation to day of last menses is observed and recorded.

研究设计

研究类型
Interventional
分配方式
Other
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 volunteers who duly signed the consent form will be considered Volunteers will be considered who will fulfil diagnostic criteria of Premenstrual Syndrome Scale.

排除标准

  • The subject found other than inclusion criteria will be excluded Subject taking any medication for any gynaecological problems like PCOS or uterine prolapse or pelvic floor prolapse or uterine fibroid.

结局指标

主要结局

change in severity of symptoms

时间窗: 0th day and 20th day

after use of Nabhi Puran

时间窗: 0th day and 20th day

次要结局

  • Any secondary effects or side effects after use of Nabhi Puran(0th day and 20th day)

研究者

发起方
Priyanka Rajkumar Bhosale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Priyanka Rajkumar Bhosale

Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune 411018

研究点 (1)

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