Study The Utility Of Repertory Of The Homoeopathic Therapeutics Of Diarrhoea By Dr James B Bell In The Management Of Acute Watery Diarrhoea In Adults An Experimental Non-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Outcome will be assessed in terms of
研究概览
简要总结
| 1A40.Z - Acute watery diarrhoea. |
Diarrhoea is an alteration in normal bowel movement, characterized by increased frequency, volume, and water content of stools. It is clinically defined as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours or more. Acute diarrhoea is defined as diarrhoea of 14 days duration or less.
Diarrhoea is loosely defined as passage of abnormally liquid or unformed stools at an increased frequency. Diarrhoea may be further defined as acute if <2 weeks, persistent if 2–4 weeks, and chronic if >4 weeks in duration.
Acute watery diarrhoea is a manifestation under "Gastrointestinal Disorders".
Causes of acute diarrhoea are mostly bacterial, viral, and parasitic infection. The route of transmission of infection is through faeco-oral route, or via eating or drinking contaminated food. Poverty and poor environmental hygiene may also contribute to infection. Acute diarrhoea may last for 7-14 days, if it occurs for more than 14days, it is called persistent diarrhoea. Diarrhoea may lead to dehydration in the body as the body tries to maintain its fluid and electrolyte balance for proper functioning but when the loss is more, the body gets dehydrated.
|ACUTE WATERY DIARRHOEA.
Diarrhoea is an alteration in normal bowel movement, characterized by increased frequency, volume, and water content of stools. It is clinically defined as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours or more. Acute diarrhoea is defined as diarrhoea of 14 days duration or less.[2]
Diarrhoea is loosely defined as passage of abnormally liquid or unformed stools at an increased frequency. Diarrhoea may be further defined as acute if <2 weeks, persistent if 2–4 weeks, and chronic if >4 weeks in duration.[3]
OBJECTIVES.
- To study the utility of repertory of The Homoeopathic Therapeutics of Diarrhoea by James B Bell in the management of Acute watery diarrhoea among adults.
2. Comparison of pre and post treatment score based on pre-validated 4 point Likert scale for acute Diarrhoea.
3. To study the rubrics related to diarrhoea from The Homoeopathic Therapeutics of Diarrhoea By James B Bell.
- To study the etiology and pathophysiology of acute watery diarhhoea.
METHODOLOGY.
I) STUDY DESIGN: An Experimental Non-Controlled Study
2) STUDY SETTING: Cases will be collected from the OPD of the Institute.
3) STUDY POPULATION: Clinically diagnosed cases of Acute watery diarrhoea among adults.
4) DURATION OF STUDY: 18 months.
5) METHODS OF SELECTION OF STUDY SUBJECT:
1. Inclusion Criteria:
Patients having Acute diarrhoea for less than 14days
Patients of age group 18-40 years
Patients of all genders
Patients with mild dehydration
2. Exclusion Criteria:
Suspected immunocompromised patients
Patients taking any medications that have confounding effect
Pregnant and lactating female
Patients with moderate and severe dehydration
Patients presenting with symptoms of any other diseases
3. Subject withdrawal criteria:
a. Patients who does not wish to continue the treatment.
b. Patients who do not give follow up regularly.
6) METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP AND MATCHING CRITERIA: Not Applicable
7) OPERATIONAL DEFINITION:
Diarrhoea- Diarrhoea is an alteration in normal bowel movement, characterized by increased frequency, volume, and water content of stools. It is clinically defined as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours or more. Acute diarrhoea is defined as diarrhoea of 14 days duration or less
Diarrhea is loosely defined as passage of abnormally liquid or unformed stools at an increased frequency. Diarrhea may be further defined as acute if <2 weeks, persistent if 2–4 weeks, and chronic if >4 weeks in duration
4 Point Likert scales used to assess symptoms of acute diarrhoea.
Symptom score
| 0 |
1
3
3
|General well being
Good
Impaired
Bad
Very bad
|Stool frequency
< 2
3-5
6-8
9
|Stool consistency
Hard or normal
Somewhat loose
Runny
Watery
|Blood or mucus in stool
None
Some
Moderate
Many
|Flatulence
Absent
Mild
Moderate
Severe
|Pain intensity
Absent
Mild
Moderate
Severe
|Pain persistency
Absent
Sporadic
Prolonged with relief after defecation
Persistant
|Nausea and/or vomiting
Absent
Mild
Moderate
Severe
3. Outcome assessment criteria
A. An overall mean total symptom score will be calculated including all subgroups which is as follows:
Unsatisfactory= 1
Satisfactory =2
Good = 3
Very Good= 4
B. Outcome Pre and Post treatment will be assessed according to 4 Point Likert scale for acute diarrhoea
Improved
Not improved
These criteria will be assessed as per the clinical symptoms presented by the patient.
SAMPLE SIZE: 30 subjects will be selected.
| DATA MANAGEMENT AND ANALYSIS PROCEDURE: |
-
Framing of totality of symptoms- Will be done as per the principles of Homoeopathy.
-
Selection of remedy- Individualized Homoeopathic Medicines based on totality of symptoms.
-
The Posology- Appropriate potency will be selected based on the susceptibility of each case. Potency will be changed when required.
-
Duration of study – 18 months
-
Duration of each case – Each case will be observed for 15 days or till improvement appeared as per decided scale.
-
Duration of follow up of each case – Every 7 days and early if required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having Acute diarrhoea for less than 14days Patients of age group 18-40 years Patients of all genders Patients with mild dehydration.
排除标准
- •Suspected immunocompromised patients Patients taking any medications that have confounding effect Pregnant and lactating female Patients with moderate and severe dehydration Patients presenting with symptoms of any other diseases.
结局指标
主要结局
Outcome will be assessed in terms of
时间窗: Duration of study- 18 month | Duration of each case- 14days or till remission of symptom. | Duration of follow up of each case- Outcome will be assessed clinically every 7 days or earlier if required.
Improved
时间窗: Duration of study- 18 month | Duration of each case- 14days or till remission of symptom. | Duration of follow up of each case- Outcome will be assessed clinically every 7 days or earlier if required.
Not improved
时间窗: Duration of study- 18 month | Duration of each case- 14days or till remission of symptom. | Duration of follow up of each case- Outcome will be assessed clinically every 7 days or earlier if required.
Based on Likerts 4 point scale for acute watery diarrhoea follow up will be carried every 7 days or earlier if required till remission.
时间窗: Duration of study- 18 month | Duration of each case- 14days or till remission of symptom. | Duration of follow up of each case- Outcome will be assessed clinically every 7 days or earlier if required.
次要结局
未报告次要终点
研究者
Dr Arsheen Shaikh
Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute
