跳至主要内容
临床试验/CTRI/2024/12/078248
CTRI/2024/12/078248尚未招募2/3 期

Clinical study on the efficacy of Karanjadi churna as add-on therapy with Baladi kashaya in Primary dysmenorrhoea

Shebeena PV1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年12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
36
试验地点
1
主要终点
Change in the mean score value of lower abdominal pain during menstruation assessed by

研究概览

简要总结

Dysmenorrhoea is defined as painful menstruation of sufficient magnitude so as to incapacitate day-to-day activities. The prevalence of Primary dysmenorrhoea was 80.9%. Most of the females with primary dysmenorrhoea described their menstrual pain as moderate to severe, which affected their daily activities and studying ability significantly. It is of two types: primary dysmenorrhoea and secondary dysmenorrhoea. Primary dysmenorrhoea is one where there is no identifiable pelvic pathology. Here the pain begins a few hours before or just with the onset of menstruation. In secondary, menstrual pain is associated with some pelvic pathologies. Dysmenorrhoea can be compared with Udavartha/Udavarthini/Udavrtta, one among 20 yonirogas mentioned in Ayurveda classics. As per Acharya Charaka, Udavarthini is due to varadhan (suppression of natural urges), which will cause aggravation of vayu which in turn leads to pain because of the tendency of menstrual blood to move in upward direction. Baladi kashaya mentioned in Chakradutta-Sulaprakarana and Karanjadi churna mentioned in Yogaratnakara-Sula chikitsa are selected for the study. Ingredients of Baladi kashaya are having anulomana, sulahara, arthavajanana, balya, rasayana, deepana, bhedaneeya, vatakaphahara. Karanjadi choorna contains Karanja, Sauvarchala, Nagara and Ramata/Hingu. Most of these drugs are having vatakaphahara, vata anulomana, sulaghna and vibandhaghna properties.The study design is Randomized Controlled Trial with sample size of 18 in each group. Female subjects of age group 15-35 years with primary dysmenorrhoea attending OPD of Prasuti tantra and Streeroga, Govt. Ayurveda College Hospital, Tripunithura will be selected for the study as per inclusion and exclusion criteria. Participants are randomly divided into Group A and Group B using the chit method. Group A will be given 2g Karanjadi churna with 48 ml Baladi kashaya twice daily before food and Group B will be given Baladi kashaya alone twice daily before food for 7 days ie, 5 days prior to next menstruation and first 2 days of menstruation for 3 consecutive periods. Assessment for pain and associated symptoms will be done on 0th day, 4th day of 1st, 2nd and 3rd cycles and same procedure will be repeated in the follow up period after 1 month. Verbal Descriptive Scale and Visual Analogue Scale will be taken for the assessment of pain, and the associated symptoms will be assessed using Verbal descriptive scale. Results will be statistically analysed afterthe study through appropriate test and conclusion will be drawn.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
15.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Subjects with Primary dysmenorrhoea, with regular periods coming to OPD of Prasuti tantra and Streeroga, Govt.
  • Ayurveda College Hospital, Tripunithura.
  • Unmarried and married nullipara within the age group of 15-35 years.

排除标准

  • Subjects diagnosed with pelvic pathology.
  • Subjects with irregular menstruation.
  • Known case of DUB.

结局指标

主要结局

Change in the mean score value of lower abdominal pain during menstruation assessed by

时间窗: 0th and 4th day of 3 consecutive menstrual cycles

Verbal Descriptive Scale and Visual Analogue Scale.

时间窗: 0th and 4th day of 3 consecutive menstrual cycles

次要结局

  • Change in associated symptoms such as nausea, vomiting,diarrhoea, low back ache, headache and giddiness as per Verbal Descriptive Scale.(0th and 4th day of 3 consecutive menstrual cycles)

研究者

发起方
Shebeena PV
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shahinamole S

Government ayurveda college

研究点 (1)

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