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临床试验/CTRI/2024/10/075638
CTRI/2024/10/075638尚未招募4 期

A Randomized Comparative Clinical Study Of Dhataki Poogi Kusum Kashaya And Bhoomyamalaki Choorna With Tandulodaka In The Management Of Raktapradara With Special Reference To Menorrhagia

Utkarsha Vishwas Lad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1)Raja Strava Kala (Duration of bleeding)

研究概览

简要总结

Menstruation is natural and normal physiological process leading to generative life in female. Normal Menstruation occurs after 21 to 35 days and last for 3 – 5 days with normal blood loss of 35-80 ml.

Menorrhagia is cyclic bleeding at normal intervals; the bleeding is either excessive in amount (>80ml) or duration (>7days) or both.

Acording to classical texts hetu sevan like excessive intake of lavan, amla, guru, katu vidahi, snigdha aahar, mansa, khichari, kheer, dadhi, alcohol etc. causes vitiation of vata which causes increase in Rakta (menstrual blood) amount and bring the increased amount of Rakta in Rajavahini seeras which results in increase in Raja. Raktapradara is caused by vitiated pitta and vata in association with Rakta.

Dhataki kusum has kashaya, katu rasa, sheeta virya and Poogi Kusum has madhur, kashaya rasa, sheeta virya which acts as Raktastambhak.5 Dhataki has potent antiinflammatory, antiandrogenic, antioxidant, astringent properties. Dhataki has katu vipak which work on mandagni present in Raktapradara. Poogi kusum is also antibacterial, antiseptic, astringent, vasoconstrictor, antioxidant in nature

In the view of cost, side effects and surgical interventions with modern medicine, the thought of exploring of Ayurvedic drugs which are having properties to reduce signs and symptoms of Raktapradara triggered this clinical research.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Patients of age 18 to 45 years.
  • Patients with complaints of excessive bleeding per vagina during menstruation.
  • Patients ready to participate in study with proper written consent.
  • Patient irrespective of religion, caste, parity, and socio-economic occupation will be included.

排除标准

  • Post-menopausal bleeding.
  • Known case of structural abnormality in genital organs.
  • Know case of malignancy.
  • Cases diagnosed with pelvic pathologies like uterine fibroid, adenomyosis, polyp, pelvic inflammatory disease, post-menopausal bleeding etc.
  • Patients using any oral contraceptive pills or IUCD or hormonal therapy.
  • Severe anemia.

结局指标

主要结局

1)Raja Strava Kala (Duration of bleeding)

时间窗: 3 DAYS OF MENSTRUAL CYCLE

2) Associated symptoms (Katishul, Adhodharshul, Angamarda)

时间窗: 3 DAYS OF MENSTRUAL CYCLE

3) Character of bleeding

时间窗: 3 DAYS OF MENSTRUAL CYCLE

次要结局

  • 1)Raja strava Pramana (Amount of blood loss)(2) Anritu Kaal (Intermenstrual period))

研究者

发起方
Utkarsha Vishwas Lad
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Utkarsha Vishwas Lad

APMS Ayurveda Mahavidyalaya Sion Mumbai

研究点 (1)

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