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CTRI Number  CTRI/2025/03/082680 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Yoga in Improving Long-term Acidity and Dyspepsia 
Scientific Title of Study   To study the efficacy of Yoga on symptom severity, psychological parameters and quality of life in patients with Functional Dyspepsia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Omesh Goyal 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Room no 9, OPD block, Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  01614688800  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Omesh Goyal 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Room no 9, OPD block, Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  01614688800  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Omesh Goyal 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Room no 9, OPD block, Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  01614688800  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India  
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore Nagar,Ludhiana, PUNJAB 141001 India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Omesh Goyal  Dayanand Medical College and Hospital  Department of Gastroenterology Room no.5
Ludhiana
PUNJAB 
9914821155

goyalomesh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DMC & Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Medical Therapy and Dietary Advice for Dyspepsia  The control group will receive Standard Medical Therapy (SMT) with traditional dietary advice (TDA)for dyspepsia. Traditional dietary advice includes- eating smaller, regular, low-fat meals and avoiding triggers like spicy foods, carbonated drinks, tea, coffee, alcohol, smoking, etc  
Intervention  Yoga  Yogic Protocol (Duration: 25 minutes) 1. Yogic Prayer - 1 minute 2. Shodhana-Kriya- 1 minute, Agnisara (twice a week) 3. Yogasanas (10 minutes) - Tadasana. Trikonasana, Ardhachakrasana, Paschimottan asana, Ushtrasana asana, Vajra asana, Manduk asana (frog pose), Bhujang asana (Cobra pose), Pawana Mukhtasana , Sethu Bandhasana( bridge pose) 4. Pranayama (8 minutes)- Nadi Shodana 5 rounds), Bhastrika 10 rounds, Kapalbbhati 30-30 2 rounds, Bhramari 5 rounds), Omkar 5 rounds 5. Relaxation , Dhyana (Meditation) 5 mins  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age 18 to 65 years
2) Patients diagnosed with Functional Dyspepsia as per Rome IV criteria
3) Able to perform yoga techniques detailed in the protocol.
4) Normal endoscopic appearance and negative H pylori testing in last 6 months  
 
ExclusionCriteria 
Details  Patients with organic cause of dyspepsia (Peptic Ulcer Disease (PUD), gastric carcinoma,
pancreatico-biliary disease etc.)
2) Patients with advanced comorbidities (chronic liver disease, advanced cardio-pulmonary,
CKD, or advanced psychiatric illness)
3) Patients with uncontrolled diabetes, hypertension or thyroid disorder
4) Patients with any abdominal surgery within past 6 months
5) Pregnant and lactating females
6) Patients not willing to provide informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The proportion of patients responding to intervention   6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of responders at 3 weeks.
Change in individual dyspepsia symptoms at 3 & 6 weeks.
Change in HRQOL (SFNDI) at 6 weeks.
Change in anxiety (PHQ9) & depression (GAD7) at 6 weeks.
Change in cumulative dose of PPI use at 6 weeks
Adherence to yoga therapy & adverse events. 
6 weeks 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Wellness encompasses a healthy body and a sound mind where, a healthy digestive system is a foundation to both. Disorders of gut-brain interaction are one of the commonest disorders in GI clinical practice [1,2].  Functional dyspepsia (FD) is one of the commonest DGBI, with prevalence in the general population of approximately 10% - 40% [3]. [4]

FD is characterized by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, or epigastric burning, which are unexplained after routine clinical evaluation. Subcategories of FD are postprandial distress syndrome (PDS), characterized by meal-induced dyspeptic symptoms, and epigastric pain syndrome (EPS), which does not occur exclusively postprandially.

Various mechanisms implicated in pathophysiology of FD include gastro-duodenal motor and sensory dysfunction, impaired mucosal integrity, low-grade immune activation, intestinal dysbiosis, dysregulation of the gut brain axis, visceral hypersensitivity, and so forth.1,2,5  Of these, visceral hypersensitivity is proposed to be the main underlying mechanism in the EPS subgroup, while disturbed GI motility, including impaired gastric accommodation to a meal and delayed gastric emptying, are thought to play a role in the PDS subgroup.[8] In addition, dysfunction of the gut-brain axis is considered to be an important determinant of symptom intensity perception in both subgroups and the available data also shows that psychological co-morbidities such as anxiety [9], depression and/or life distress play a key role in the development of the disease.[10,11,12,13,14] As measured by rating scales in various studies, Generalized anxiety disorder (GAD) and Major depressive episodes (MDE) along with poorer psychological wellbeing are often found to be related to dyspepsia [15] but, their relevance to how specific comorbid psychological disorders contribute to the clinical and societal burden of dyspeptic symptoms, still remains unclear.[16]

Although FD is not a life-threatening disease, but it impairs quality of life, put a notable negative impact on work productivity of a patient, and increases health care costs for both the patients and society.[17] Our group validated both Hindi and English version of Short Form Nepean Dyspepsia Index (SFNDI) in Functional Dyspepsia patient. 

Generally, treatment of FD should be based on the etiology of the condition but due to the complexity of the disease, the current strategy for pharmacological treatments is empirical.[18] As per ACG guidelines, H. pylori eradication treatment, is recommended as the first line treatment therapy for the treatment of FD, while acid inhibitory drugs, such as proton pump inhibitors (PPIs) and prokinetics like acotiamide, following the use of psychotropic agents like tricyclic antidepressants has been suggested as second line therapy.[19]  However, most of these pharmacological treatments have only modest effectiveness, and are associated with side effects on long-term use, and none has been proven to alter the long-term natural history of FD.2,6 

Therefore, the interest of patients in non-conventional treatment options is rising over the last decade.[21,22] Even the practitioners have also started to incline towards the complementary and alternative medicines (CAM). This incorporates a wide variety of approaches, including acupuncture, moxibustion, herbal medicine, dietary interventions, homeopathy, osteopathy, microbial therapy using probiotics, meditation, chiropractic, cupping, massage, yoga, Qigong etc. [23,24]

At present, yoga is being adapted by many patients worldwide in an attempt to reduce stress and improve overall health. As mood and digestive system health are closely linked via the gut-brain connection, [25] therefore, the rational management of the digestive disorders involves consideration of the  entire  psychosomatic  factors. This makes mind and body therapies the potential areas of interest in the management of DGBIs. [26,27] Rebalancing of the autonomic nervous system is essential for mental and emotional stability; which can be contributed by regular practice of yoga.[28] Any disharmony between body and mind has the potential to cause an adverse health effect and yoga is the science that focuses on bringing that harmony between the two. Therefore, the goal of yoga is to strengthen the muscles and the nervous system, with the goal of reaching a balance of the body and mind.[29] Yoga has been practiced for thousands of years and is an integral part of traditional Indian medicine[30] adapted for use in complementary medicine, especially with regard to preventing and treating the disease.[31]  Traditionally, yoga consists of body postures (Sanskrit: Asana), breathing exercises (Pranayama) and meditation (Dhyana); a practice to “still the mind”[32,33] while the modern practice of yoga, especially within Western cultures, has evolved and is primarily associated with a variety of poses involving stretching and breathing exercises, often performed in combination with meditation.[34] Yoga helps to strengthen the muscles of digestive system, ultimately improving the circulation of nutrients, is considered safe, economical and a natural panacea for pathologies related to digestive system.[35]

It is hypothesized that yoga practice corrects stress-induced underactivity of the parasympathetic nervous system and has been shown to reduce stress and psychological distress [36,37], factors that are known to play a prime role in the onset and persistence of DGBIs. Evidence for the benefit of yoga and their effects on various outcomes, including gastrointestinal symptoms, quality of life, anxiety and mood is available in few review studies.[38] The available data depicting the efficacy of yoga, solitary focuses mostly on bowel disorders like IBS and CC [39,40,41]. To date, no studies have yet explored the efficacy of Yoga in FD patients. This study aims to evaluate the effect of Yoga on symptoms and psychological parameters in patients with functional dyspepsia.

 

 
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