A Comparative Clinical Study to Evaluate the Efficacy of Shatavari Kalpa with Vaginal Gel and Shatpushpa Kalpa with Vaginal Gel in Managing Perimenopausal Symptoms with Reference to Oxidative Stress.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Research report will be soon published after the completion of trial 40 patients fulfilling the
inclusion and exclusion criterias will be randomly selected from the OPD and IPD of
department of Prasuti Tantra evum Stri Roga , RGGPG Ayurvedic College and Hospital
Paprola Distt Kangra HP. Patients will be divided into 2 groups of 20 each.
- Patient will be managed with Shatavari Kalpa orally with Shatavari Vaginal Gel intravaginally in 1 group. 2. Patient will be managed with Shatapushpa Kalpa orally with Shatapushpa Vaginal Gel intravaginally in 2 group.
Total Duration: The total duration of the study will be 12 weeks (84 days).
Follow-up Schedule: Participants will be assessed at baseline and followed up at the 4th week, 8th week, and 12th week.
Visit 1 (Baseline Assessment): At baseline, a detailed symptom assessment will be carried out using the Menopause Rating Scale (MRS) and Vaginal Health Index Score (VHIS). Oxidative stress markers will be evaluated. Participants will also be staged according to the STRAW +10 criteria.
Visit 2 (4th Week Follow-up): At the 4th week, participants will undergo a compliance check. Symptom assessment will be performed, and any adverse effects will be monitored and recorded.
Visit 3 (8th Week Follow-up): At the 8th week, compliance with the intervention will again be assessed. Symptom evaluation will be conducted, and adverse effects will be monitored.
Visit 4 (12th Week – Final Assessment): At the end of 12 weeks, final symptom assessment will be done using MRS and VHIS. Oxidative stress markers will be re-evaluated, and final outcome assessment will be performed to determine the efficacy of the intervention.
Result will be assessed on the basis of subjective and objective criteria.
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
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female aged between forty and fifty-five years experiencing perimenopausal symptoms.
- •Classified as perimenopausal according to the STRAW plus ten criteria.
- •Early perimenopause defined as menstrual cycle variability of seven days or more.
- •Late perimenopause defined as amenorrhea for sixty days or more but less than twelve months.
- •Menopause Rating Scale score of ten or more.
- •Vaginal Health Index Score of ten or more.
- •Willing and able to participate for a duration of twelve weeks.
排除标准
- •Patients with evidence of malignancy.
- •Patients who have undergone surgical menopause.
- •Established cases of any mental illness.
- •Prolonged use of drugs affecting study outcomes for more than six weeks, including corticosteroids, antidepressants, anticholinergics, and hormone replacement therapy.
- •Patients with major systemic diseases requiring long term treatment.
- •Patients who are alcohol dependent and or drug dependent.
- •History of hypersensitivity to any of the trial drugs or their ingredients.
- •Any other condition which the Principal Investigator considers may jeopardize the study.
研究者
Prof Soni Kapil
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Kangra H.P.