A Cross-Sectional Observational Study of Association between Circadian Rhythm Alteration and Doshic Imbalance in Night Workers having Amlapitta and A Clinical Comparative Study to Evaluate the Effect of Yavadi Kwatha and Amlapitta Mishran in Amlapitta
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the Amlapitta Symptom Rating Scale score compared to baseline
研究概览
简要总结
PHASE 1 – OBSERVATIONAL STUDYRESEARCH QUESTION:
Is there any association between doshic imbalance and circadian rhythm alteration among night workers having Amlapitta
HYPOTHESIS
Null Hypothesis [H01]- There is noassociation between doshic imbalance and circadian rhythm alteration among night workers having Amlapitta.
Alternative Hypothesis [H****A] – There isassociation between doshic imbalance and circadian rhythm alteration among night workers having Amlapitta.
4. AIM: To study the association between circadian rhythm alteration and doshic imbalance among night workers having Amlapitta.
Primary Objective
To correlate serum cortisol levels with circadian rhythm alteration and doshic imbalance as a biomarker of physiological stress.
Secondary Objectives
- To assess the distribution of chronotypes (morning, intermediate, evening types) among night workers using the Morningness-Eveningness Questionnaire (MEQ).[i]
- To identify the predominant doshic imbalance (Vata, Pitta, Kapha, or their combinations) associated with circadian rhythm disturbances.
- To explore the relationship between the degree of circadian misalignment and the severity of doshic imbalance.
[i] https://www.med.upenn.edu/cbti/assets/user-content/documents/Morningness-Eveningness%20Questionnaire.pdf
PHASE 2 – CLINICAL STUDYRESEARCH QUESTION:
Is there any difference in efficacy of Yavadi Kwatha and Amlapitta Mishran in management of Amlapitta among night workers?
HYPOTHESIS:
Null Hypothesis [H01]:There is no difference in the efficacy of Yavadi Kwatha and Amlapitta Mishranin managing Amlapitta in night workers.
Alternate Hypothesis [HA]:There is a difference in the efficacy of Yavadi Kwatha and Amlapitta Mishran in managing Amlapitta in night workers.
AIM:
To compare difference in the efficacy of Yavadi KwathaandAmlapitta Mishran in managing Amlapitta among night workers.
OBJECTIVES:Primary Objective:To evaluate efficacy of Yavadi Kwatha and Amlapitta Mishran Suspension in improvement of Amlapitta Symptom Rating Scale from baseline to day 30.
Secondary Objectives To evaluate efficacy of Yavadi Kwatha and Amlapitta Mishran Suspension in improvement of Post Prandial Distress Syndrome (PPDS) score from baseline to day 30.
To evaluate efficacy of Yavadi Kwatha and Amlapitta Mishran Suspension in improvement of Epigastric Pain Syndrome (EPS) score from baseline to day 30.
To assess the safety of Yavadi Kwatha and Amlapitta Mishran Suspension on GERD Scale score from baseline to day 30.
ASSESSMENT CRITERIA
Amlapitta Symptom Ratings Scale: Scale of 0-21
| Grades of severity |
Score
Characteristics
|Avipaak (Indigestion)
|G0
0
no indigestion
|G1
1
digests normal usual diet in 09 hours
|G2
2
digests normal usual diet in 12 hours
|G3
3
digests normal usual diet in 24 hours or more
|Klama (Tiredness)
|G0
0
no tiredness
|G1
1
feel tired after exertion work
|G2
2
feel tired after normal work
|G3
3
feel tired even after taking rest
|Utklesha (Nausea)
|G0
0
no nausea
|G1
1
Feel nausea after eating some peculiar food
|G2
2
feel nausea after eating all kinds of food
|G3
3
full day nausea, not related to eating
|Tikta amla udgaar (Sour and bitter belching)
|G0
0
no sour and bitter belching
|G1
1
sour and bitter belching after taking spicy food
|G2
2
sour and bitter belching after taking any type of food
|G3
3
sour and bitter belching having no relation with food intake
|Guruta (Feeling of heaviness in the body)
|G0
0
no feeling of heaviness in the body
|G1
1
heaviness after taking more quantity of heavy food
|G2
2
heaviness even after taking light food
|G3
3
heaviness even on empty stomach
|Hrit-Kantha Daha (Burning sensation)
|G0
0
no Burning sensation
|G1
1
burning sensation after intake of spicy food
|G2
2
feeling of burning sensation even after intake of normal food
|G3
3
burning sensation even empty stomach
|Aruchi (Anorexia)
|G0
0
no anorexia
|G1
1
eat food only two times without any snacks in between
|G2
2
eat only once
|G3
3
have no feeling of appetite
|Total score range: 0-21
Functional Dyspepsia is divided into Postprandial Distress Syndrome (PPDS) and Epigastric Pain Syndrome (EPS). Criteria for PPDS and EPS will be recorded on a Likert scale to see improvement in the symptoms at the end of treatment.
Postprandial Distress Syndrome (PPDS) Diagnostic Criteria score:
Bothersome postprandial fullness severe enough to impact on usual activities) – Likert scale of 1 (very mild) to 5 (very severe).
Bothersome early satiation severe enough to prevent finishing a regular-size meal) – Likert scale of 1 (very mild) to 5 (very severe).
Epigastric Pain Syndrome (EPS) Diagnostic criteria score:
Bothersome epigastric pain severe enough to impact on usual activities) - Likert scale of 1 (very mild) to 5 (very severe).
Bothersome epigastric burning severe enough to impact on usual activities) - Likert scale of 1 (very mild) to 5 (very severe)
GERD Health Related Quality of Life (GERD HRQL) Questionnaire
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Night workers of either sex Presence of Amlapitta as diagnosed by Amlapitta Symptom Rating Scale Score of 5 or more Participants willing to give written informed consent.
- •Currently engaged in night shift work (Ratrojagaran will be considered 12 pm to 6am minimum of 3 months, more than 5 nights/month).
排除标准
- •Pregnant or lactating women.
- •Participants with documented H pylori infection.
- •Participants with history of psychiatric disorders including eating disorders.
- •Participants documented with chronic degenerative diseases including uncontrolled hepatic, renal or endocrine diseases (except diabetes controlled by oral hypoglycaemic agents or controlled hypothyroidism) malabsorption or chronic diarrhoea, history of seizures or epilepsy, gastric surgery or participants with oncological diseases.
- •Participants with history of gastroesophageal surgery and surgery to reduce the secretion of gastric acid.
- •Participants with history of oesophageal varix (varices) Participants with history of malignant neoplasm of gastrointestinal tract.
- •Participants with history of thrombosis or administered with anti-thrombotic drugs.
- •Participants administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 1 weeks.
- •Participants with history of Zollinger-Ellison syndrome Participants documented with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •History of life threatening cardiovascular and /or neurological event in the past one year.
- •Participants with history of drug abuse, bleeding disorder.
- •Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
- •Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
- •History of HIV or any immune deficient conditions.
- •Participants on corticosteroid, sleep medication, antipsychotic drugs.
结局指标
主要结局
Change in the Amlapitta Symptom Rating Scale score compared to baseline
时间窗: 30 Days
次要结局
- Enhancing awareness of circadian health and Dosha management through Ayurvedic principles.(Change in the PPDS symptom scale compared to baseline)
研究者
Suryawanshi Payal Prataprao
National Institute of Ayurveda