An Anatomical study of Talahridaya Marma and Role of Talahridaya Marma Chikitsa and Sarpaghandha Ghan Vati in the Management of Prehypertension :A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in JNC criteria
研究概览
简要总结
Need of the Study
Hypertension is a prevalent disorder that affects a significant proportion of the global population. Despite the existence of various antihypertensive treatments, the prevalence of hypertension is on the rise not only among the elderly population but also among young adults. Currently the modern medicinal treatment involves various drugs for the treatment of hypertension and a longer intake of such medicines comes with its own side effects on the human body. Considering these reasons, Marma chikitsa could be a better alternative to the current practise of treating hypertension. Clinicians who practise Marma chikitsa have observed a normalising effect on blood pressure, through this non-invasive method of treatment, hypertension and other diseases associated with it could be treated in a holistic manner [5]. Although the lack of clinical data on the effectiveness of this chikitsa has resulted in its limited application across various diseases, thus leaving its potential largely unexplored [3].
In Marma chikitsa a very light stimulation of Marma points on the body is done. Marma points when gently pressed on the skin can stimulate a chain of flow of Prana. Marma chikitsa can make the treatment easy without any medicinal use. Therefore, an attempt is made through this study to treat and manage prehypertension.
Aim*:*
· Compare the efficacy of Talahridaya Marma chikitsa with Sarpagandh Ghan Vati in the management of prehypertension.
Objectives:
1. An anatomical study of Talhridaya Marma.
2. To evaluate the effectiveness of Talahridaya Marma chikitsa in the management of prehypertension.
Statement of Hypothesis
Null Hypothesis (Ho):
• There is no difference in the effect of Talahridaya Marma Chikitsaand Sarpaghandha ghan vatiin the management of prehypertension.
Alternative Hypothesis (Ha):
• Talahridaya Marma Chikitsais more beneficial thanSarpaghandha ghan vatiin the management of prehypertension.
Outcome**:**
Change in JNC criteria
Materials and Methods
Step 01: Conceptual Study
· Detail study of Talahridaya Marma as per Ayurveda classic and through cadaveric study
· Detail study of hypertension as per modern literature
Step 02: Interventional study
An interventional open randomize trial involving 30+30 volunteer with the age group of 21-50 years of either gender will be taken for the study. For clinical study, patient attending OPD of Rachana Sharir in National Institute of Ayurveda (NIA) Arogyashala, SSBH and Satellite Hospital, Jaipur will be selected randomly with the symptoms of prehypertension.
Patients Selection Criteria
Inclusion Criteria:
· Patients lying within the age group of 21-50 years.
· Patient is currently not taking any drugs for hypertension.
· Patient will come under the prehypertension range = 120-139 mm of Hg systolic BP to 80- 89 mm of Hg Diastolic BP.
Exclusion Criteria:
· Patient who are suffering from acute systemic disease
· Pregnant lady, lactating mothers and females who have recent history of abortion.
· Patient coming under the range of grade 1 and grade 2 hypertension.
Withdrawal Criteria (Any of the following):
· Patient himself /herself wants to withdraw from the trail.
· Serious adverse reaction where continuation of the study pauses a serious risk to the participant.
· Participant’s condition deteriorates during the course in the opinion of the clinician i.e., further continuation of the study is likely to be detrimental to health of participant.
· Development of clinical condition leads to violation of inclusion /exclusion criteria.
Methodology
1. Study Design: Open labeled randomized controlled clinical trial
· Study Type: Randomized controlled clinical trail
· Purpose: Treatment of pre-hypertension
· Masking: Open label
· Number of Groups: 02 groups
2. Sampling Method: Random Sampling
· Randomization: Computer generated random number table
· Sample Size: 60 (each group assigned 30 patients)
3. Research Design: Interventional study
· Study Duration: 30 Days
· Follow up: 15 days
4. Reference: Ayurveda.Sar Sanghra and Siddha Yoga Sanghra
5. Ingredients of Drug: Sarpaghandha Ghan Vati
| Drug name |
Botanical name
Part
|01.
Sarpagandha
Rauvolfia serpentine
Root
|02.
Khurasani yavani
Trachyspermum ammi
Seed
|03.
Jatamansi
Nardostachys jatamansi
Rhizome
|04.
Bhanga
Cannabis sativa
Leaf
|05.
Pippalimoola
Piper longum
Root
Groups
The selected patient will be randomly divided into two group viz group A and group B on the basis of computer-generated random number chart. There will be equal number i.e., 30 patients in each group.
Group A: 30 Patients
- Patients will be given Marma chikitsafor a period of 30 days.
- Chikitsa period: maximum 30 days
- Follow up: 15 days
- Chikitsa protocol: Three times stimulations in one sitting (Two sitting in a day)
- Technique - by Pulp of 3 finger side to side movement.
- Marma to be stimulate: Talahridaya Marma
Group B: 30 Patients
- Patients will be given Sarpaghandha Ghan Vati.
- Dose- 125 mg BD
- Time- After food
Assessment Criteria
· JNC Criteria
| BP Classification |
SBP (mmHg)
DBP (mmHg
|Normal
≈120
≈80
|Prehypertension
120-139
80-89
|Stage 01 Hypertension
140-159
90-99
|Stage 02 Hypertension
160
100
Table 1: Classification of Hypertension
· Lipid Profile
Statistical Analysis
1. Paired t-test
2. Unpaired t-test (between comparison)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient lying within the age group of 21-50 years Patient is currently not taking any drugs for hypertension Patient will come under the prehypertension range 120-139 mm of Hg systolic BP to 80-89mm of Hg diastolic BP.
排除标准
- •Patient who are suffering from acute systemic disease Pregant lady,lactating mothers and females who have recent history of abortion Patient coming under the range of grade 1 and grade 2 hypertension.
结局指标
主要结局
Change in JNC criteria
时间窗: 30 days
次要结局
- Improvement in the patient condition(30 days)
研究者
Chanchal Yogi
National institute of ayurveda, jaipur
