跳至主要内容
临床试验/CTRI/2025/02/080801
CTRI/2025/02/080801尚未招募Phase 3 4

Clinical study of effect of Amla Kanji Bhavit Japadi Vati in comparison with progesterone pills on delayed menses (Artavakshaya).

Dr Netra Shankar Bhadale1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月1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
20
试验地点
1
主要终点
After completion of medicine course (1-7 days) menstruation will be started.

研究概览

简要总结

Reproductive health of the female is best judged by menstrual cycle. According to Ayurveda, normal menstruation is the prime indicator of healthy and normal reproductive system, in which inter menstrual period is approximately one month.  For the menstruation to occur, the HPO axis must be actively coordinated, endometrium must be responsive to the ovarian hormones (estrogen and progesterone) and the outflow tract must be patent. Now a days, due to changing lifestyle and stress, menstrual disorders are of great concern-delayed menses is one of them. The length of menstrual cycle varies from woman to woman, but average is 28 days. However, a cycle can range in length from 21 - 35 days and still be normaL.

Delayed menses (oligomenorrhea) literally means absence of menstruation more than 35 days in previously normal menstruation in non-pregnant woman. Common causes of delayed menses are Stress, Post pills, Psychotropic and Antihypertensive drugs, Pituitary Adenoma and Sheehan’s Syndrome, PCOS, Premature ovarian failure, Uterine synechiae, Malnutrition, hypothyroid state and Diabetes.1The treatment opted in modern system of medicine is hormonal therapy. So, to prevent repeated use of hormonal therapy, its better to use safe Ayurvedic non-hormonal drug formulation as quoted in *Bhaishajya Ratnavali Yonivyapadrogadhikar is proposed.

Conduct of procedure:

  1. Patient is examined in opd , necessary investigation done, considering inclusion exclusion criteria , subjects will be recruited in trial group or control group.

  2. Trial drug is given, patient asked for follow up after 7 days from last dose of medication or 3rd day of menses whichever is earlier.

  3. Effect is observed and noted.

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 40.00 Year(s)(—)
性别
Female

入选标准

  • Period of amenorrhea more than 35 days with negative UPT.

排除标准

  • 1.Patient with pregnancy and lactation.
  • 2.Patient with known case of hypertension,DM,Thyroid diseae 3.Patient with severe anemia 4.Patient with congenital anomaly of female genital tract.
  • patient with malignancy of genital tract.
  • patient with primary amenorrhea.

结局指标

主要结局

After completion of medicine course (1-7 days) menstruation will be started.

时间窗: After completion of medicine course (1-7 days) menstruation will be started.

次要结局

  • regular normal flow menstruation.(3rd day of menstruation or 7 day after last dose of medication.)

研究者

发起方
Dr Netra Shankar Bhadale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Netra Shankar Bhadale

Bharati Vidyapeeth.

研究点 (1)

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