Randomized Controlled Trial of Shigru Mool Churna in Management of Mutrashmari.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the effect of Gokshur Churna in the management of Mutrashmari. To compare the efficacy of Shigru Mool Chuma and Gokshur Churna in management of Mutrashmari.
研究概览
简要总结
TITAL Randomized Controlled Trial of Shigru Mool Churna in Management of Mutrashmari.
Research question
Whether Shigru Mool Churna is effective in management of Mutrashmari thn Gokshur churna ?
NULL HYPOTHESIS : Shigrumul churna and Gokshur churna is equally effective in the management of Mutrashmari.
Alternative Hypothesis [H1]:
Shigru Mool Churna is more effective than Gokshur churna in management of Mutrashimari.
STANDARD OPERATING PROCEDURE GROUP A (TRIAL GROUP)
Patient will be selected from O.P.D. and I.P.D. for clinical trail of drug. At first visit of patient after screening, written consent will be taken.
observation will be recorded.
18
GROUP B (CONTROL
GROUP)
Gokshur churna
Drugs
evening before meal)
Oral
for 30days
GROUP A (TRIAL GROUP)
Shigru Mool Churna
evening before meal)
Oral
Drinking Water
Drinking water
for 30days
150 gm of Churna of Shigru Mool will be given. Patient advised to take 5gm with provided 5gm spoon at morning and evening before meal. After completion of 15 days next 150 gm power sachet with 5gm spoon will be provided.
A proforma for dairy drug consumtion diary will be provided to patient.
patient will advised to come every week so that continuity of treatment and
Patient will be advised diet regime as per instruction designed for particular study.
(CONTROL GROUP)
.
Patient will be selected from O.P.D. and 1.P.D. for clinical trail of drug
At first visit of patient after screening, written consent will be taken.
150 gm of Churna of Gokshur will be given. Patient advised to take 5gm with
provided 5gm spoon at morning and evening before meal. After completion of 15
days next 150 gm power sachet with 5gm spoon will be provided.
A proforma for dairy drug consumtion diary will be provided to patient.
The patient will advised to come after a week so that continuity of treatment and
observation will be recorded. Patient will be advised diet regime as per instruction designed for particular study.
DISCUSSION:- Data obtained assessment will be analyzed and will be decided in final dissertation.
CONCLUTION
On the basis of available literature, observation and discussion will be precisely drawn and whole dissertation will be summarized .
4)HYPOTHESIS
Churna?
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of Age group 18-60 years.
- •Patients irrespective of gender, religion, economical, status education occupation.
- •Patient having calculi size up to 10mm in kidney, ureter and bladder.
- •Patients having suffering from Mutrashmari without any major illness.
- •Mutrashmari with intervention.
- •no other consequences and reluctant for 6 Patient will be selected after base line investigation.
- •Co-operative patients.
排除标准
- •Patient having calcull of size more than 10mm.
- •Acute retention of urine.
- •Hydronephrosis.
- •Impaired renal function.
- •Patient having severe obstructive uropathy.
- •Patient requiring emergency surgery like obstructed urinary calculi.
- •Malignancy
- •Non co-operative patient.
结局指标
主要结局
To study the effect of Gokshur Churna in the management of Mutrashmari. To compare the efficacy of Shigru Mool Chuma and Gokshur Churna in management of Mutrashmari.
时间窗: 1 months | Size and symptoms are the parameters will be assist
次要结局
- To provide alternate management principle to patient of Mutrashmari.(To study literature regarding drug and disease)