A comparative clinical study to evaluate the effect of draksharishta as a physical health promoter in treated cases of rajayakshma vis-a-vis pulmonary tuberculosis
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
- Improvement in physical health and less symptoms compared to control group
研究概览
简要总结
NEED FOR STUDY
Swasthasya Swasthyarakshanam, Aturasya Vikaraprashamanam, is the main aim of Ayurveda which describe the importance of maintaining and promoting the health in addition to treating illness.
Diseases are destroyers of health and well being, which is infectious, communicable and health deteriorating are explained in Ayurveda.
Rajayakshma is one of them which is considered aupsargika vyadhi (communicable disease) and also is asadhya as it is associated with loss of strength and muscle wasting due to kshaya.
Sahasa, vega sandarana, kshaya, vishamashana, are the four causes of rajayakshma and shows its symptoms like pinasa, shwasa, kasa, aruchi, vitsamsrana, chardi all leads to kshaya or shosha of the body.
Rajayakshma can be correlated with pulmonary tuberculosis in modern science, in which the rasadi dhatus gets diminished, leading to decreased strength and activity levels, it is also known as rogarat, the king of diseases, governing all other illnesses.
In 2023, incidence of TB increased slightly to 27.8 lakh from the previous year’s estimation of 27.4 lakh.
The disease itself and DOTS treatment can diminish the physical health of the patient and is a challenging task for the physician to revive undernourished health into normalcy and also to prevent the recurrency of the infection due to impaired immunity. Even the government provides monthly support of Rs.500 to nearly 1crore beneficiaries for undernourished TB patients estimated 7.44 lakh as reported in 2022.
In Ayurveda, to treat the undernourishment in PTB infected person, numerous methods and medications has been indicated. One such formulation explained in bhaishajya ratnavali is draksharishta as balya.
Hence, this is a trial taken to see the effect of draksharishta in treated cases of PTB to improve and promote the physical health status particularly focusing on weight and physical attributes.
AIMS & OBJECTIVE OF THE STUDY
-
To evaluate the effect of draksharishta as physical health promoter in treated cases of PTB
-
To evaluate the physical health of the wait list subjects in treated cases of PTB.
-
To compare the efficacy of draksharishta and wait list subjects in treated cases of PTB
SAMPLE SIZE:
30 subjects diagnosed with PTB (irrespective of gender) and completed Treatment protocol will be taken into 2 groups based on randomized sampling method.
Group A-15 subjects (wait list group)
Group B-15 subjects (interventional group)
PLAN OF TREATMENT:
GROUP A: Sample Size- 15 subjects(wait list group)
GROUP B:
Sample size- 15 subjects(interventional group)
Subjects after fulfilling the criteria and after taking informed consent.
Draksharishta will be procured from GMP certified pharmacy and will be given in Dose-25ml BD after food with equal quantity of water for 45days.
ASSESSMENT CRITERIA:
Subjects will be assessed before and at the end of the month on 0th day, 15th day, 30th day, 45th day and follow up on 90th day by using following scales
OBJECTIVE:
-
Weight
-
BMI
-
Mid Arm circumference
-
Skin fold thickness
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects between the age of 18-45 years irrespective of gender and socio-economic status.
- •PTB subjects after completion of DOTS treatment protocol.
- •Subjects willing to participate in the study.
排除标准
- •Pregnant women and lactating mother with PTB.
- •PTB subjects who are under treatment.
- •PTB subjects with diabetes mellitus.
- •Extrapulmonary TB and Surgical PTB cases
- •HIV and PTB coinfection
- •PTB subjects infected with STDs.
结局指标
主要结局
Improvement in physical health and less symptoms compared to control group
时间窗: 45th day
次要结局
- Maintanence of imporved in physical health and less symptoms compared to control group(90th day)
研究者
Dr Shivani Parganiha
JSS Ayurveda medical college and hospital