A single arm study to evaluate the effect of an ayurvedic treatment protocol for the management of diminished ovarian reserve
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1)Improvement in Ultrasonography count of ovarian antral follicles, Antral follicle count (AFC) - on Day 2/3 of the menstrual cycle 2)Improvement in serum anti-Mullerian hormone (AMH) – Day 2/3 of the Menstrual Cycle
研究概览
简要总结
Diminished ovarian reserve patients have low Anti Mullerian Hormone (AMH) values and Antral Follicle Count (AFC).An Ayurveda treatment protocol based on Artava kshaya chikitsa found clinically improving Anti Mullerian Hormone (AMH) and Antral Follicle Count (AFC).Hence the role of Ayurveda in managing DOR by improving either AMH value or AFC must be studied and validated. In the future, it will benefit DOR patients to have ART procedures with their eggs and thus opening a wide scope for research in integrated medicine. The patients who opt for natural pregnancy also benefit as it improves the quality and quantity of oocytes. Also, it benefits the patients by improving their overall menstrual health. Hence the specific Ayurvedic treatment protocol mentioned for Artavakshaya chikitsa can be tested for its efficacy in managing Diminished Ovarian Reserve.
The aim of this single arm study is to evaluate the effect of an Ayurveda treatment protocol in 25- 40-year-old Diminished Ovarian Reserve patients. For this 24 patients satisfying inclusion and exclusion criteria will be recruited to the study. The primary outcome measure is improvement of serum anti-Mullerian hormone (AMH) level and Improvement of Ultrasonography count of ovarian antral follicles, Antral follicle count (AFC) which will be assessed before and after treatment. Secondary outcome measure is to assess in every visit the change in Menstrual cycle pattern in terms of frequency, quantity and duration an change in Vaginal dryness / pain.
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
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participant willing and able to give informed consent for participation in the trial 2)Diagnosed with Diminished ovarian reserve serum AMH less than 1.1 ng/ml, AFC less than 7 follicles 3)Participants with regular menstruation associated with either scanty menstruation or vaginal dryness or hot flashes or other peri menopausal symptoms.
排除标准
- •Diagnosed of genetic disorders 2)Undergoing treatment for malignancy 3)Undergoing treatment for systemic pathologies like DM, HTN, HDL 4)History of oophorectomy 5)Known case of Poly cystic ovarian syndrome.
结局指标
主要结局
1)Improvement in Ultrasonography count of ovarian antral follicles, Antral follicle count (AFC) - on Day 2/3 of the menstrual cycle 2)Improvement in serum anti-Mullerian hormone (AMH) – Day 2/3 of the Menstrual Cycle
时间窗: Assessment before treatment (BT) will be done during recruitment and post assessment after treatment (AT) will be done after three months of Ayurvedic treatment.
次要结局
- 1)Assessment of menstrual cycle in terms of Frequency, Duration, and Volume(2)Vaginal dryness or vaginal pain)
研究者
Dr Anjaly MV
Amrita School of Ayurveda