跳至主要内容
临床试验/CTRI/2020/04/024739
CTRI/2020/04/024739尚未招募2 期

A Randomized open label comparative clinical study of Shatapushpa Kalpa with Shatapushpa taila matra basti and Tilashelukaravi kwatha in the management of Artava Kshaya

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
To regularize menstrual cycle with normal flow of menstrual bleeding.

研究概览

简要总结

Physiological changes and development occurs right from birth but markedly during the age of puberty. Due to increased physical and emotional stress in routine life style of women alters the physiology of “Hypothalamus-Pituitary-Ovarian-Uterine axis.†This condition may lead to many gynecological problems. Among all gynecological problems, the most common one menstrual problem is Artava Kshaya being more common. On reviewing our Ayurvedic classics we found that “Artava Kshaya†is not explained as a disease in any texts where as it has been described very systematically as a symptom of so many gynecological disorders in many classics.

Artava Kshaya has been explained by Acharya Sushruta- In this condition, menstruation is delayed, menstrual blood is scanty & associated painful menstruation. Artava Kshaya has also been mentioned in Astha Artava Dushtis as Ksheen Artava. In allopathic science Lakshana of Artava Kshaya can be correlated with certain menstrual disorders as follows :

Yathochita kala adarshanam as Irregular menses or Oligomenorrhoea

Alpata as Hypomenorrhoea

Yonivedana as Dysmenorrhoea

So when we compare the disease Artava Kshaya with the modern medical science Oligomenorrhoea and Hypomenorrhoea can be correlated on the basis of its signs & symptoms.

Rationality of Drug :

Acharayas has mentioned that the Artava is Agneya in nature and Achrayas also mentioned the concept of “Samanayam Vridhikarnamâ€. In line of treatment of Artava Kshaya, Acharaya Sushruta has mentioned Samshodhana and use of Agneya Dravyas. So in this study agneya dravyas will be used which will work by the Vridhi of *Samaandharmi Artava.*Shatapushpa to be used in study is Tikta & Katu in rasa, Ushna in Virya, has laghu-teekshna guna, vatashamaka and also been mentioned to have property Ritupravrtini.

On pharmacological screening Shatapushpa is found to have antispasmodic, antioxidant,

antibacterial, antidiabetic and anticancer activities.

Tilashelukaravi  are having Artavapravartaka properties like they are Ushna Virya, Vatashamka , Kaphashamka due to which they will have better action on Rajorodha and will lead to Artavapravartana. Along with all this tila also have Vednasthapana property which will work on painful menstruation. On pharmacological screening Tila is found to have antioxidant , hepatoprotective activities. Shelu is found to have  Immunomodulator, antidiabetic, hepatoprotective, antioxidant activities. Karvi is found to have antispasmodic, analgesic, anti inflammatory activities

The procedure that is chosen to administer Shatapushpa Taila in this trial is Matra Basti. Acharya Charaka described Matra Basti as Sarvkala Niratyayathat is it can be given any time without any complications. It is mentioned to have Balya, Brihmana, Vataroganuta5 properties

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

入选标准

  • •Age- 15-40 years, Married/ Unmarried patients having any of following symptoms :-
  • •Patient willing and able to participate in the study with written informed consent.
  • •Consent will be taken from guardian of those patient below 18 years of age.
  • •Duration of flow less than 3 days with reduced quantity of flow (using less than 2 pads/day) with or without pain.
  • •Patients suffering from 2 consecutive cycles of Oligomenorrhoea and or Hypomennorhoea both.

排除标准

  • •Patients having physiological infrequent menstruation.
  • •Pregnant women.
  • •Lactating mothers
  • •Women taking OCPs.
  • •Patients suffering from any systemic diseases.
  • •Patients having any organic pathology of uterus and adnexa.
  • •Hb. level less than 7 gm%.

结局指标

主要结局

To regularize menstrual cycle with normal flow of menstrual bleeding.

时间窗: after 8 weeks

次要结局

  • Relief in associated features like painful menstruation etc.(after 8 weeks.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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