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临床试验/CTRI/2025/02/081379
CTRI/2025/02/081379尚未招募2/3 期

A Comparative Clinical Evaluation Of Shalmali Ghrit And Shatvari Ghrit In The Management Of Asrigdar

Government Ayurvedic P.G. College And Hospital Chaukaghat Varanasi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Normalization of Menstrual Cycle

研究概览

简要总结

Interventional study

Patient suffering from Asrigdar will be selected from OPD and IPD of Department of

Prasuti Tantra evum Stri Roga , Government PG Ayurvedic College and Hospital Chaukaghat

Varanasi.

Total 60 patients will be selected for the study of the drug. Treatment will continue for 3 consecutive months (90 days).

Treatment protocol - patients are divided into two groups of 30-30 patients.

GROUP-A (TREATMENT GROUP):

It consists of 30 patients who will be given the selected drug SHALMALI GHRIT orally.

Dose: 10ml BD in PRAGBHAKT kala from first day of the menstrual cycle up to 14 days, for 3 consecutive months.

GROUP-B (CONTROL GROUP):

It also consists of a group of 30 patients who will be given SHATAVARI GHRIT orally.

Dose: 10ml BD in PRAGBHAKT kala from the first day of menstrual cycle up to 14 days, for 3 consecutive months.

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
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients who are willing to participate in the trial, including both married and unmarried individuals, will be included.
  • The primary eligibility criterion is the presence of Asrigdara as a cardinal symptom.

排除标准

  • Patients who are not willing to participate in the trial will be excluded.
  • Additionally, individuals with hemoglobin levels below 8 gm%, pregnant patients, and lactating women will not be considered.
  • Those using intrauterine contraceptive devices (IUCDs) or oral contraceptive pills (OCPs) are also ineligible.
  • Exclusion criteria further include bleeding from sites other than the uterus, bleeding due to abortion, postmenopausal bleeding, and systemic illnesses such as severe hypertension, liver dysfunction, thyroid disorders, and sexually transmitted diseases (STDs).
  • Patients with coagulation disorders or those diagnosed with uterine and pelvic pathologies, including fibroids, adenomyosis, pelvic inflammatory disease (PID), endometrial polyps, and cervical cancer, will also be excluded from the study.

结局指标

主要结局

1.Normalization of Menstrual Cycle

时间窗: 3 Months

2.Reduction in Spotting or Pre-menstrual Bleeding

时间窗: 3 Months

次要结局

  • Improvement in associate symptoms like angamarda kathishool aruchi daurbalya bhram tamoPravesh tandra etc(3 Months)

研究者

发起方
Government Ayurvedic P.G. College And Hospital Chaukaghat Varanasi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pooja Sahu

Government Ayurvedic PG College And Hospital Chaukaghat,Varanasi

研究点 (1)

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