Efficacy of Shatavaryadi Kashaya along with Shatavari Ghrita ointment in the management of genitourinary syndrome of menopause - an open labelled randomised standard control clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in the symptoms of Genitourinary Syndrome of Menopause (GSM), measured by standardized symptom scoring tools -Vaginal Health Index (VHI), Female Sexual Health Index (FSHI), Urinary tract infection symptoms assessment (UTISA)
研究概览
简要总结
Purpose of the research: Research of Genitourinary urinary syndrome of menopause can enhance early diagnosis, treatment options and overall management, leading to better health outcomes for women, particularly in aging populations. Addressing GSM can improve sexual health, reduce discomfort from urinary symptoms, and prevent complications like recurrent UTIs. Research on this topic is crucial to improving the quality of life for postmenopausal women. By focusing on the prevalence, impact, and treatment of this condition, especially in regions like India, we can reduce the underdiagnosis and undertreatment of GSM and provide better, culturally relevant care for women worldwide.
Information on the Trial procedure and Drug: [Group A - Shatavaryadi Kashaya orally along with per vaginal application of Shatavari ointment Group B - Multivitamins supplement orally along with per vaginal application of estradiol ointment. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.Description of the Process: In this present research work, 70 patients according to inclusion criteria will be selected and on the basis of computerized randomization, Patients will be divided into 2 groups,Group A: Deepana & Pachana with Guduchi, Haritaki and Sunthi Choorna will be given orally 3 days prior to administration of Shatavaryadi Kashaya. 20 gm of coarsely powdered drugs should be boiled with 16 parts of water in steel vessel, over a mild flame till the liquid is reduced to 1/4th of the original quantity. 40 ml of Shatavaryadi Kashaya with 5 ml of Goghrita Prakshepa will be given before meal to patient. 2-gram Shatavari ointment per vaginal application/ day at bedtime will be given to the patient. This treatment will be continued for 60 days. Drugs will be prepared in the Pharmacy of ITRA, Jamnagar.
Group B: Multivitamins tablet and estriol ointment will be purchased from Pradhan Mantri Jan Aashaadha Kendra Jamnagar or other authentic medical store. Weltive 4G - Multivitamins tablet once/day after breakfast will be given to the patient along with estriol ointment 0.5 mg/twice a week will be advised to patients for 60 days. Follow-up: Patients will be advised to visit the hospital every 2 weeks during the treatment period (2 months). Follow up will be done for every 2 weeks after the completion of treatment to assess the status of the patient for 1 month. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects.Results: The efficacy of the therapy will be assessed on the basis of subjective and objective criteria. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Genitourinary syndrome of menopause. Collected information from this research project will be kept confidential, all outcomeswill be noted in tabular form and appropriate statistical tests will be applied to compare the effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Postmenopausal women (equal or more than 12 consecutive months since last menstrual period) 2.Age 40-65 years 3.Presence of at least 3 common symptoms of GSM i.e. Yoniraukshya, Yonikandu, Mutrakruccha, Mutradaha, Yonivedana, Yonidaha (vaginal dryness, vaginal itching, dysuria, burning micturition, dyspareunia, burning sensation per vagina).
- •4.Women with a confirmed diagnosis of menopause (natural- absence of menstruation for 12 months or more than that) or surgical- A history of bilateral oophorectomy or hysterectomy with or without bilateral salpingo-oophorectomy) 5.Willing to provide informed consent and comply with study protocol.
排除标准
- •1.Women under 40 or over 65 years of age.
- •2.Premenopausal women or those with irregular menstrual cycles.
- •3.Current use of systemic hormone replacement therapy (HRT) or vaginal estrogen treatments.
- •4.Active vaginal or severe urinary tract infections associated with fever, chills.
- •5.History of cervical, ovarian, endometrial, vaginal, vulvar and breast cancer.
- •6.Severe pelvic organ prolapses or other gynecological disorders requiring surgical intervention.
- •7.Current use of medications that affect sexual function or vaginal health(e.g,certain antidepressants, antihistamines).
- •8.Subjects with uncontrolled HTN (Blood Pressure equal or more than 150/100 mm of Hg) and Diabetes (RBS equal or more than 200 mg/dl).
结局指标
主要结局
Reduction in the symptoms of Genitourinary Syndrome of Menopause (GSM), measured by standardized symptom scoring tools -Vaginal Health Index (VHI), Female Sexual Health Index (FSHI), Urinary tract infection symptoms assessment (UTISA)
时间窗: 60 Days
次要结局
- Changes in the vaginal maturity Index.(Improvement in Quality of life of postmenopausal women.)
研究者
Anjana Thanki
Institute of Teaching and Research in Ayurveda,Jamnagar