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临床试验/CTRI/2023/10/058399
CTRI/2023/10/058399尚未招募Phase 3 4

EVALUATION OF EFFICACY OF KANYALOHADI VATI IN UDAVARTINI YONIVYAPATH VIS A VIS TO PRIMARY DYSMENORRHOEA -AN OPEN LABEL SINGLE ARM CLINICAL STUDY

Dr Sonal Singh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
this study is done for symptomatic management of pain in primary dysmenorrhea with ayurvedic tablet kanyalohadi vati

研究概览

简要总结

•      As  per Ayurveda  predominant factor for dysmenorrhoea  is Vata.  Apanavata is  the  governing force  of  menstruation.  Its  vitiation  gives  rise  to   diseases under the entity of   yonivyapada’s Udavartini is  one  among them, where   vitiated Vata  moves  in  pratiloma gati leading to ‘painful menstruation’.  The  treatment   indicated is  normalization  of Vata.[1]

•        As dysmenorrhoea  is  one  of  the  most  common complaints amongst adolescents, it affects the quality of life  of  many  women  in  their  reproductive  age , Because  of  sedentary  life  style and  food  habits  this  problem  is increasing  day  by  day worldwide.  About 25-50%  of  adult  women  and  about  75%  of  adolescents experience  pain  during  menstruation,  with  5  -20% reporting  severe  dysmenorrhea  [2]. Dysmenorrhoea can also be associated with nausea, vomiting, diarrhea, fatigue,  which  disturbs  routine  activities . Dysmenorrhoea   is   the  leading  cause of short term school  absenteeism.  It  is associated  with  a  negative impact on social, academic and sports activities of many female adolescent [3].

•      As in cases of udavartini yoni vyapatha, vataprakopa is the main cause, the treatment should be directed to treat the vitiated  vata and to eradicate  the cause ,hence an attempt is made to treat with vatahara, vataanuloma and vedanasthapana dravyas .

As the drug which is used is palatable, cost effective and can be taken easily with busy schedule and will impact effective cure without any inconvenience .

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 32.00 Year(s)(—)
性别
Female

入选标准

  • Age group 16-32 years -patient with regular cycles complaining of painful menstruation for at least three consecutive cycles.

排除标准

  • Pelvic pathology – Known case of Fibroid, Adenomyosis, Endometriosis, PID, Menorrhagia, Malignancy.
  • Patients with intrauterine contraceptive devices or on contraceptive pills.
  • Congenital anomalies of reproductive system.
  • Metabolic disorders – known case of Diabeties Mellitus , Hypertension , Thyroid dysfunction.

结局指标

主要结局

this study is done for symptomatic management of pain in primary dysmenorrhea with ayurvedic tablet kanyalohadi vati

时间窗: 30 Days

次要结局

  • this medicine will help to get rid of painful menses experience , & will not lead to effect the day to day activity(90 days)
  • Symptomatic Relief In The Symptoms(90 Days)

研究者

发起方
Dr Sonal Singh
申办方类型
Other [self]

研究点 (1)

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