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临床试验/CTRI/2024/09/073611
CTRI/2024/09/073611尚未招募3 期

Single arm clinical trial to evaluate the efficacy of Brahmighrita in Premenstrual Syndrome.

Dr Bhandwalkar Priyanka Annasaheb1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月1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
30
试验地点
1
主要终点
The effect of treatment is assessed on the basis of

研究概览

简要总结

Premenstrual syndrome or PMS is psycho-neuro-endocrine disorder consisting of constellation of mood and behavioral or physical symptoms that have regular clinical relationship to the luteal phase of menstrual cycle. Symptoms includes anger outburst, anxiety, confusion, irritability, abdominal bloating, breast tenderness, headache, joint pain etc. Serotonin and GABA neurotransmitters in the luteal phase may be responsible for the symptom complex. Luteal phase can be considered as Rituvyatitakala as per ayurveda. PMS does not have any direct co-relation in Ayurveda but can be considered as a Tridosha disorder with Pitta dominance and Vata  SanchayaavasthaBrahmi ghrita is chosen for treatment of PMS as it has Medhya, Rasayana, Balya properties.Brahmi ghrita has been indicated for Vandhya which shows its effect on proper functioning of HPO axis. Chemical constituents of Brahmi i.e Brahmine, Monnierin acts on neurotransmitter, dopamine & GABA receptor. Sunthi also known as Vishwabhaishaja relieves all type of pain including colicky pain, joint pain, headache and menstrual Pain. All these qualities of Brahmighrita makes it suitable choice for treatment. therefore, an attempt is made to study the clinical evaluation of Brahmighrita in the management of Premenstrual Syndrome.

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
16.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients fulfilling diagnostic criteria 2) Women in age group of 16-40 years not using any hormonal contraceptives.
  • Woman having regular menstrual cycle.

排除标准

  • Patient with diagnosed case of psychiatric disorder i.e neurodevelopment disorder, schizophrenia etc.
  • Patient diagnosed with any pelvic pathology like endometriosis, inflammatory disease.
  • Systemic disorders like Chronic renal diseases, Cardiac disorders, Tuberculosis, Hypertension, Diabetes, Thyroid dysfunctions.
  • Patients with Premenstrual dysphoric disorder.
  • Females using oral contraceptives pills, IUCD, injectable contraceptives.

结局指标

主要结局

The effect of treatment is assessed on the basis of

时间窗: Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle

a) Subjective Criteria –

时间窗: Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle

Symptoms appear during 7 days prior to menstrual cycle

时间窗: Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle

b) Objective Criteria-

时间窗: Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle

Symptomatic analysis based on PMS scale screening

时间窗: Treatment duration is given for 2 menstrual cycle and follow-up is taken in third menstrual cycle

次要结局

  • The effect of treatment is assessed on the basis of(a) Subjective Criteria –)

研究者

发起方
Dr Bhandwalkar Priyanka Annasaheb
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Bhandwalkar Priyanka Annasaheb

Alvas Ayurveda Medical College And Hospital Moodubidire

研究点 (1)

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