A Pilot Study On Effectiveness of Parangi Rasayanam (Internal) and Padigara Neer Peechu (External) For Vellai Noi(Leucorrhoea)
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
Poonguzhal Isai kavi
National Institute of Siddha and Dr. MGR medical University
