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临床试验/CTRI/2023/06/053385
CTRI/2023/06/053385尚未招募2/3 期

An Anatomico-clinical study on comparative effect of Gulpha Marma Chikitsa & Yavani Churna in Primary Dysmenorrhoea (Krichhartava)

Faculty of Ayurveda IMS Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月6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
90
试验地点
1
主要终点
Reduced Intensity and Duration of pain during menstruation

研究概览

简要总结

Dysmenorrhoeais the most common gynecological problem faced by female during adolescencewhich causes significant discomfort and anxiety for the woman as well asfamily. Primary Dysmenorrhoea is described as a pain that is of uterine originand directly linked to menstruation but with no visible pelvic pathology. Theincidence of Primary Dysmenorrhoea of sufficient magnitude with incapacitationis about 15-20%. Primary Dysmenorrhoea is extremely common, especially amongadolescents, as many as 90% of adolescent females and above 50% of menstruatingwomen worldwide report suffering from it, with 10-20% of them describing theirhurt as sever and distressing.

Inthe classics of Ayurveda, Dysmenorrhoeais mentioned as symptom in many disorders like VatalaYonivyapada, Sannipatiki Yonivyapada, Paripluta Yonivyapada, Mahayoni,Udavartini Yonivyapada, Antarmukhi Yonivyapada, Suchimukhi Yonivyapada.

The main cause of Primary Dysmenorrhoea (Krichhartava*)*  is vitiation of  Vatadosha (Apana and VyanaVata)  which should be correctedthrough the drugs of  Vatashamaka and Vatahara properties.

Krichhartava has strong relation with Vata Dosha because pain does not occur without vitiation of Apana Vata Dushti. As normalmenstruation is the attributed to the ApanavayuKarma and hence painful menstruation is related with the vitiation of Vata especially the Apana Vayu, so painful menstruation is related is considered as Apana Vata Dushti.

Plan of study

Total 90 patients of age group 14 to 45 years withsign and symptoms of Primary Dysmenorrhoea (*Krichhartava)*without any other complications will beregistered from the OPD of Prasuti Tantra, S.S. Hospital (Ayurveda wing), IMSBHU, Varanasi, by following proper assessment of inclusion and exclusioncriteria developed for the present research work and will be divided into threegroups as follows:

Groupingof Cases-Allthe registered patients will be divided randomly in three trial groups A, B andC by computerised method.

GroupA- (30 cases): GroupA will be treated with Yavani churna(2gm, in two divided dose) for duration of 90 days, 10 days prior to expecteddate of menses for 3 consecutive cycle.

GroupB-(30 cases): GroupB will be advised to do Gulpha Marmastimulation daily in the morning and evening as per technique described belowfor 3 months.

Group C-(30 cases): Controlled group Cwill be treated with Placebo treatment (placebo capsule 1BD), nothing specialadvice.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
14.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1Patients willing to participate in study.
  • 2Age group between 14 to 45 years.
  • 3Unmarried and married both patients attending the OPD with chief complain of Primary Dysmenorrhoea with scanty or average amount of menses along with associated symptoms without any organic pathology.
  • 4patients suffering more than two cycles.

排除标准

  • 1Patients below 14 years and above 45 years.
  • 2Any abnormalities detected in investigation.
  • 3Coagulation disorders.
  • 4Patients suffering from chronic systemic disease like uncontrollable diabetes, uncontrollable hypertension, venereal disease, thyroid dysfunction or any disorders influencing general physical health and ultimately influencing menses.
  • 5Patients using IUCD and OCPs or injectables contaceptive and others.
  • 6Patients with any history of allergy or allergy from trial drugs.
  • 7Patients having Central nervous system disorders like epilepsy, meningitis, migraine or any other psychological disorders.
  • 8Patients having Respiratory disorders like bronchial asthma, T.B., pleural effusion, bronchitis etc.
  • 9Patients having any carcinoma.

结局指标

主要结局

Reduced Intensity and Duration of pain during menstruation

时间窗: Before intervention and | Every month after intervention for 4 months

次要结局

  • Relief in associated sign and symptoms(Before intervention and)

研究者

发起方
Faculty of Ayurveda IMS Banaras Hindu University
申办方类型
Research institution and hospital

研究点 (1)

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