An Open Labelled Single Arm Clinical Study To Assess The Role Of Tiladi Ghanavati Orally In Artavakshaya With Special Reference To Polycystic Ovarian Morphology (Bulky Ovaries).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- To Study The Role Of Tiladi Ghanvati in Atavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries).
研究概览
简要总结
**TITLE -**An Open Labelled Single Arm Clinical Study to Assess the Roll of Tiladi Ghanavati Orally
In Artavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries).
Methodology -
**1.****Type of study design -**Single armclinical study.
**2.**Study population– Diagnosed Patients of Artavakshayawith special reference to Polycystic
Ovarian Morphology (Bulky Ovaries).
**3.**Method Of Sample Selection-Sequential Sampling.
**4.**Sample Size – 87
**5.**Duration of study–Duration of study will be approx. 18 months
**6.**Inclusion criteria–
a. Patients suffering from1or more typical Lakshanasof Artavakshaya(Oligomenorrhea, Hypomenorrhea)and with Polycystic Ovarian Morphology (Bulky Ovaries).
b. Patients of age group 20-35 years.
c. Patient selection will be irrespective of marital status, parity and dosh prakruti.
d. Patients having scanty menses having menstrual flow less than 3 days as compared to previous menses.
e. Patients ready for clinical trial.
**7.**Exclusion criteria–
a. Patient with operable organic, congenital or acquired defect in female genital tract.
b. Patients taking oral contraceptive pills or taking Contraceptive Injectable and having IUCD’s, etc.
c. Patients taking anti-depressant therapy.
d. Patients having systemic disease like DM, HTN, Anemia, HIV, HBsAg, VDRL, Tuberculosis.
e. Uterine fibroid, Complex ovarian cyst, Dermoid cyst, Tuboovarian mass.
f. Patients with Hormonal imbalance.
g. Patients suffering from uterine Synechiae (Intrauterine adhesions or Asherman), Malignancy, Endometriosis.
h. Pregnancy, lactating and post-natal and perimenopausal female.
**8.**Withdrawal criteria –
a. If patient develop any adverse effect.
b. If aggregation of symptoms occurs.
c. If patient refuses to continue the treatment.
d. If patient never comes for follow up.
e. Patients who are taking irregular medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •a.Patients suffering from 1 or more typical Lakshanas of Artavakshaya (Oligomenorrhea, Hypomenorrhea) and with Polycystic Ovarian Morphology (Bulky Ovaries).
- •b.Patients having scanty menses having menstrual flow less than 3 days as compared to previous menses.
排除标准
- •a.Patient with operable organic, congenital or acquired defect in female genital tract.
- •b.Patients taking oral contraceptive pills or taking Contraceptive Injectable and having IUCD’s, etc.
- •c.Patients taking anti-depressant therapy.
- •d.Patients having systemic disease like DM, HTN, Anemia, HIV, HBsAg, VDRL, Tuberculosis.
- •e.Uterine fibroid, Complex ovarian cyst, Dermoid cyst, Tubo ovarian mass.
- •f.Patients with Hormonal imbalance.
- •g.Patients suffering from uterine Synechiae (Intrauterine adhesions/ Asherman), Malignancy, Endometriosis.
- •h.Pregnancy, lactating and post-natal and perimenopausal female.
结局指标
主要结局
To Study The Role Of Tiladi Ghanvati in Atavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries).
时间窗: To Study The Role Of Tiladi Ghanvati in Atavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries).
次要结局
- 1)To study Polycystic Ovarian Morphology (Bulky Ovaries) in detail.(2)To study the adverse effect of Tiladi Ghanavati which can be occurred during study.)
研究者
Dr Suchita B Rajebhosale
Yashwant Ayurvedic college, Post Graduate Training And Research Centre,Kodoli,