Assessment of Annavaha Srotodushti Hetu and Lakshana in Amlapitta and Upashayatmak effect of Jeerakadya Ghrita: A Single Arm Open Label Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita.
研究概览
简要总结
“Bala Arogya Ayuscha Pranascha Agnou Pratistitha.”[1] according to Acharya Charaka, the power of Agni, or normal condition of Agni, is responsible for proper health, longevity, and vital breath. Acharya Vagbhata says that Roga Sarveapi Mandagnou.[2] Mandagni is the primary cause of all diseases. So, Agni plays a crucial role in understanding the development of illness, diagnosis, and therapy protocols. In the modern era, Amlapitta is the one of the most prevalent disease conditions of Annavaha Strotas. Ayurveda says that Pitta is of 2 types Prakrita and Vaikrita. In this condition, Pitta becomes Vaikrita or Vidagdha because the Amlaguna of Pachaka Pitta increases due to their similarity. [3]
Amlapitta is one of the commonest Annavaha Srotasvyadhi, caused by vitiation of three Doshas, specifically Pachaka pitta, Samana vata, Kledaka kapha. When excessive intake of Virudha, Dushta, Amla, Vidhahi, Pitta prakopaka ahaar is consumed itcauses Mandagni that leads to Vidagdhajeerna manifesting as Amlapitta in Amashaya, with the lakshanas as avipaka, klama, uthklesha, amlaudgara, daha, aruchi [4] etc. The Annavaha srotas is the one that bears a direct impact of all the dietetic errors that a person indulges.[5] Most of the gastrointestinal disorders are owing to results from abnormal functioning of agni, faulty diets like, pungent, spicy food, irregular meals pattern, habits like smoking, alcohol consumption, and psychological stress.
NEED OF STUDY
• Amlapitta is a prevalent gastrointestinal disorder in Ayurvedic practice, often comparable to GERD in modern medicine. The Annavaha Srotas, responsible for the transportation and digestion of food, play a crucial role in its pathogenesis. Despite classical references to Srotodushti Hetu (pathogenic factors) and Lakshana (clinical features), there is a lack of systematic clinical correlation and scientific validation of these concepts in the context of Amlapitta. A focused study is needed to elucidate the role of Annavaha Srotas dushti in the etiopathogenesis of Amlapitta, which may enhance diagnostic accuracy & therapeutic efficacy.
AIM AND OBJECTIVES-
OBSERVATIONAL STUDY
AIM :
To evaluate the involvement of Annavaha strotdushti Hetu and Lakshana in Amlapitta.
Primary Objective-
• To study the pathological role of Annavaha Strotas in Amlapitta through Annavaha Srotas Hetu & Lakshana assessment questionnaire*.*
Secondary Objective-
• To analyze the relationship of salivary pH with the Amlapitta symptoms.
INTERVENTIONAL STUDY:
AIM-
To assess the Upashayatmak effect of Jeerakadya ghrita in Amlapitta.
Primary Objective-
• To evaluate the Upashayatmak effect of Jeerakadya ghrita inthemanagement of Amlapitta with reference to Amlapitta Symptom Rating Scale and increase in Salivary pH.
Secondary Objective-
• To assess the before and after effect of Jeerakadya Ghrit on pepsinogen 1& 2 in patients of Amlapitta.
10. OUTCOME MEASURES
OBSERVATIONAL STUDY :
Primary outcome: Relationship between Annavaha Strotodushti hetu and lakshana and symptoms of Amlapitta.
Secondary outcome: Relationship betweenSalivary pH and symptoms of Amlapitta.
INTERVENTIONAL STUDY :
Primary outcome:
1. Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita.
2. Change in salivary pH from baseline to post-treatment, indicating the effect of therapy.
Secondary outcome: Change in pepsinogen levels, serving as a biochemical marker to assess symptom relief.
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
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Newly diagnosed Amlapitta patients (based on Ayurvedic signs and symptoms like Avipaka, Klama, Utklesha, Amla-tikta udgara, Gaurava, Hrit-kantha daaha, Aruchi) attending O.P.D of AIIA 2.Willing to provide informed consent and follow study protocol.
- •3.Patients with deranged Annavaha srotas functions as assessed through Annavaha Srotodushti Hetu and Lakshan Questionnaire.
排除标准
- •1.Pregnant or lactating women.
- •2.History of infections or GI conditions (e.g., hepatitis, HIV, peptic ulcer, esophageal varices).
- •3.Substance abuse (alcohol, tobacco, or drugs).
- •4.Ongoing hormonal or psychosomatic treatment.
- •5.Patients with poor dental health.
- •6.Patients with controlled Diabetes mellitus, Hypertension, cardiovascular, neurological disorders, malignancies, hemorrhoids, thyroid disorders.
结局指标
主要结局
1.Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita.
时间窗: 1.Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita.
2. Change in salivary pH from baseline to post-treatment, indicating the effect of therapy.
时间窗: 1.Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita.
次要结局
- Change in pepsinogen levels at 30th day of intervention to assess symptom relief(0th & 30th day)
研究者
Dr Pakhrani Priyanka Mohanlal
All India Institute of Ayurveda
