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临床试验/CTRI/2025/07/091058
CTRI/2025/07/091058尚未招募不适用

A Blinded comparative diagnostic study of Naadi examination and progesterone Assay in a consecutive series of patients with features of anovular Menstruation attending NIS

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
The percentage of Specificity, Sensitivity of Siddha Naadi examination in diagnosis of Anovulation with ovulation will be obtained

研究概览

简要总结

This is a prospective, blinded, comparative diagnostic study conducted at Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai, over 18 months. The study aims to evaluate the effectiveness of Siddha Naadi examination in diagnosing anovulatory menstruationin women aged 20–45 years, by comparing it with the gold standard progesterone assay. A total of 100 female participants, 50 participants with with menstrual irregularities (like menorrhagia, oligomenorrhea, metrorrhagia) and 50 with regular menstruration  will be enrolled. They will undergo hormonal testing (FSH, LH, estrogen, progesterone, etc.) and ultrasound follicular studies. Anovulation will be confirmed through a progesterone dipstick test**.** Participants will then be randomly and blindly presented to the principal investigator, who will perform Naadi examination without knowing the patient’s identity or diagnosis. An additional (unblinded) investigator will assess Naadi beforehand for comparison. The primary objective is to determine the sensitivity andspecificity of Naadi in detecting anovulation. Secondary objectives include calculating the positive and negative predictive values, likelihood ratios, and documenting Naadi patterns across different stages of anovulation. This study is expected to provide scientific validation for the diagnostic utility of Siddha Naadi examination in reproductive health.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients who are affected with menstrual irregularity a.
  • oligomenorrhea b.
  • metrorrhagia c.
  • menorrhagia II.
  • Progesterone Dipstix for confirming anovulation III.
  • USG Abdomen/ pelvis /Transvaginal (follicular study).

排除标准

  • Pregnancy and Lactating mother ii.
  • Participants with other cardiac diseases iii.
  • Kidney diseases and arterial diseases iv.
  • Mental retardation, and psychiatric issues v.
  • Participants in emergency conditions/post-operative hospitalized patients.

结局指标

主要结局

The percentage of Specificity, Sensitivity of Siddha Naadi examination in diagnosis of Anovulation with ovulation will be obtained

时间窗: BASE LINE

次要结局

  • I. Different Naadi patterns if observed in different grades/stages will be documented.(ii. The percentage of positive predictive value and negative predictive value, Likelihood Ratio( LHR) will be obtained)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Suthajanani Loganathan

National institute of siddha Tambaram Sanatorium Chennai 47

研究点 (1)

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