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临床试验/CTRI/2025/08/093925
CTRI/2025/08/093925尚未招募不适用

A Pilot Study On Effectiveness of Parangi Rasayanam (Internal) and Padigara Neer Peechu (External) For Vellai Noi(Leucorrhoea)

National Institute of siddha1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
Significant reduction in clinical symptom which is assessed by using Leucorrhea assessment scale.

研究概览

简要总结

AIM:

To determine the effectiveness of Parangi Rasayanam (Internal ) and Padigara neer Peechu (External ) for Vellai Noi (Leucorrhoea)

OBJECTIVES:

To assess the improvement in clinical symptoms of leucorrhoea using leucorrhoea assessment scale before and after treatment.

MATERIALS AND METHODS:

STUDY PLACE

Out Patient Department, Sool Magalir Maruthuvam,

Ayothidoss Pandithar Hospital, National institute of Siddha, Tambaram Sanatorium, Chennai -47.

STUDY PERIOD : 6 months

STUDY TYPE : Experimental STUDY DESIGN : Open clinical study SAMPLE SIZE : 10 patients

SAMPLE METHOD : Consecutive sampling method

STUDY DRUG :

Parangi Rasayanam (Internal)

Ref : Agasthiyar Rathina Surukkam.

DRUG STORAGE:

The trial drug Parangi Rasayanam (internal) will be stored in clean air tight

container.

DOSAGE

6 gm (2 times a day)

Adjuvant : Milk

Duration : 40 days

Padigara Neer Peechu[6] (External)

Duration : 40 days (3 days once)

DISPENSING:

The medicine will be provided from NIS OP Dispensary

SUBJECT SELECTION:

Patients reporting with symptoms of inclusion criteria will be documented by using screening proforma.

INCLUSION CRITERIA:

Women in reproductive age group

Age group: 18 to 55 years

Inclusion will be dine based on leucorrhoea assessement scale

Patients who are willing to sign the informed consent

EXCLUSION CEITERIA:

Pregnancy & lactation

Known case of sexually transmitted disease (Syphilis, HIV, Gonorrhoea)

Known medical history of uterine or cervical polyp

Known medical history of uterine prolapse

Known case of Malignancy in uterus & ovary

Known case of gardnerella vaginalis

OUTCOME OF STUDY:

Significant reduction in clinical symptom which is assessed by using Leucorrhea assessment scale.

ASSESSMENT SCALE[6]:

Vaginal discharge

  • No vaginal discharge

  • Mild - Occasionally wetting undergarments / slight discharge, vulval moistness

  • Moderate discharge, wetting of undergarments

3- Severe - Heavy discharge which needs vulval

Backache

  • No pain

– Mild - Can withstand pain & can manage routine work

– Moderate - Cannot manage routine work & need to take rest

– Severe - Cannot withstand pain & bed ridden

Itching of vulva

  • No itching

  • Mild - Slight rub

  • Moderate - Instant rub causing redness

  • Severe - Continuous rub causing redness

Burning of vulva

  • No burning

  • Mild - Occasional burning

  • Moderate - Frequent burning

  • Severe – Continuous

Odour

  • Absent

  • Mild

  • Moderate

– Severe

Symptoms

0

(None)

1

(Mild)

2

(Moderate)

3

(Severe)

Vaginal discharge

Backache

Itching of vulva

Burning of vulva

Odour

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
18.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Women in reproductive age group Age group: 18 to 55 years Inclusion will be done based on leucorrhoea assessement scale Patients who are willing to sign the informed consent.

排除标准

  • Pregnancy & lactation Known case of sexually transmitted disease (Syphilis, HIV, Gonorrhoea) Known medical history of uterine or cervical polyp Known medical history of uterine prolapse Known case of gardnerella vaginalis.

结局指标

主要结局

Significant reduction in clinical symptom which is assessed by using Leucorrhea assessment scale.

时间窗: Significant reduction in clinical symptom in 40 days duration which is assessed by using Leucorrhea assessment scale.

次要结局

未报告次要终点

研究者

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

Poonguzhal Isai kavi

National Institute of Siddha and Dr. MGR medical University

研究点 (1)

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