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CTRI Number  CTRI/2026/02/104974 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Study To See How Well Nux Vomica Works In People With Acid Reflux . 
Scientific Title of Study   To Assertain The Efficacy Of Nux Vomica In Gastroesophageal Reflux Diseases Based On Allens Keynotes And Clarke Dictionary Of Practical Materia Medica By Utilising Health Related Quality of Life Scale. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Jitendrabhai Patel 
Designation  PG Scholar 
Affiliation  C.D. Pachchigar College of Homoeopathic Medicine and Hospital. 
Address  C.D.Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor Near Navjivan Circle Udhana Magdalla Road Surat.

Surat
GUJARAT
395001
India 
Phone  6352488006  
Fax    
Email  anjalipatel2542001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh P Khatri 
Designation  Associate Proffesor of Homoeopathic Materia Medica 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital. 
Address  C.D.Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor Near Navjivan Circle Udhana Magdalla Road Surat.

Surat
GUJARAT
395001
India 
Phone  9429012500  
Fax    
Email  mukeshkhatri5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh P Khatri 
Designation  Associate Proffesor of Homoeopathic Materia Medica 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital. 
Address  C.D.Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Homoeopathic Materia Medica Post Graduation Division 2nd Floor Near Navjivan Circle Udhana Magdalla Road Surat.

Surat
GUJARAT
395001
India 
Phone  9429012500  
Fax    
Email  mukeshkhatri5@gmail.com  
 
Source of Monetary or Material Support  
C.D.Pachchigar College of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat. 395001 GUJRAT INDIA 
 
Primary Sponsor  
Name  C.D.Pachchigar College of Homoeopathic Medicine And Hospital 
Address  C.D.Pachchigar College of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat. 395001 GUJRAT 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 
Anjali Jitendrabhai Patel  C.D.Pachchigar college of Homoeopathic Medicine And Hospital.  Department Of Homoeopathic Materia Medica Post Graduation Division 2nd floor.
Surat
GUJARAT 
6352488006

anjalipatel2542001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee of C.D.Pachchigar Coll  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Nux Vomica (Homoeopathic Medicine)  Homoeopathic Medicine Nux Vomica will be Prescribed to patients diagnosed with Gastroesophageal Reflux Disease based on indication from Allens keynotes and Clarkes Dictionary of Practical Materia Medica. Potency (30C/200C/1M) selection according to Patients susceptibility.The total planned duration of intervention will be 6 weeks,during which follow up assesment will be conducted every 2 weeks. If Patients require more than 6 weeks Duration of intervention will be extended for the 12 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient age 18 to 50 years.
Patients of both sex.
Patient Diagnosed by Clinically OR Radiologically and PatientAlready Diagnose with GERD.
Patient with or without taking any conventional treatment.
Patient symptoms similar to the Totality of Symptoms of Nux vomica Describe in Allens keynotes and Clarke dictionary of practical Materia medica. 
 
ExclusionCriteria 
Details  Cases which having advanced pathology like GI Malignancy,
esophagitis, And Barret’s esophagus.
Complication of Gastroesophageal reflux disease.
Pregnant or lactating women.
Less than 18 and More than 50 years of age. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Evaluate the Efficacy of Nux Vomica in Gastroesophageal Reflux Disease By utilising Health Related Quality of life scale.  9 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Gastroesophageal Reflux Disease symptoms score(Health Related Quality of life Scale).  9 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/03/2026 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

6.

REVIEW OF LITRATURE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INCLUDING RECENT STUDY TO RELEVENT PRESENT DISEASE:

1. An open -label pilot study to explore usefulness of Homeopathic treatment in nonerosive gastroesophageal reflux disease.  (1)

     In this study involved administration of homeopathic medicine to each patient with presenting symptoms of GERD. The Response  of this treatment was evaluated using parameters including  the GERD symptoms score, by visual analog(VAS) scale. Finding from this study indicated a notable decrease the score of GERD symptoms after symptoms.

2.Usefullness of Robinia pseudoacacia in treatment of Gastroesophageal Reflux disease.  (2)

     This study aimed to investigate  the potential therapeutic value of Robinia pseudoaccasia  has a long history of use for various gastric issues when administer in physiological dose. This study shows improvement of GERD symptoms with treatment.

3.The study  of homeopathic  medicines for treatment in gastroesophageal reflux disease.  (3)

     The homeopathic medicine such as nux vomica ,arsenic album, lycopodium clavatum, sulphur, and other remedies showed marked improvement in treatment in GERD.In conclusion , the study suggests that homeopathic medicines are effective in the treatment of gastroesophageal reflux disease.

PRESENT KNOWLEDGE GAP FOR THE STATED PROBLEM:

   Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal disorders, often associated with impaired quality of life due to its chronic and recurrent nature. Conventional management focuses mainly on symptomatic control through proton pump inhibitors and lifestyle modifications, but long-term dependence and relapse are common.

     In Homoeopathy, Nux Vomica is frequently indicated in cases of gastric irritation, acidity, and dyspepsia resulting from sedentary habits, dietary excess, or mental stress. Classical authors such as J.H. Clarke and H.C.Allen have vividly described the clinical and characteristic features of Nux Vomica in their respective writings — Clarke emphasizing its broad clinical application and Allen highlighting its  keynotes and modalities.

  Despite these detailed descriptions in the Materia Medica, there is limited clinical evidence assessing the effectiveness of Nux Vomica in GERD using standardized evaluation tools. Few studies have attempted to validate the indications provided by classical authors in present-day clinical conditions through objective outcome measures.

 Therefore, a knowledge gap exists in systematically evaluating the clinical utility of Nux Vomica in the management of GERD, based on classical Materia Medica references and assessed through the Health-Related Quality of Life (HRQL) scale. The present study aims to bridge this gap by applying Nux Vomica in GERD cases as indicated by Clarke and Allen, and by analyzing its impact on patients’ quality of life through a standardized assessment tool.

JUSTIFIES RESERCH QUESTION:

   The research question is justified as Nux Vomica is a frequently used homeopathic remedy with wide clinical applications. However, comparative understanding of its indications from Clarke’s and Kent’s classical texts remains unexplored. This study aims to assess their perspectives to enhance the clinical utility of Nux Vomica in present-day practice.

REFERENSIS FROM THE CLASSICAL TEXT BOOKS

GASTROESOPHAGEAL REFLUX DISEASE

 DEFINATION- Gastroesophageal reflux disease is defined as backward flow of gastric contents into the esophagus. (5) Gasroesophageal refkux disease is caused by recurrent reflux of gastric content into distal oesophagus. (6)

PATHOPHYSIOLOGY

  Occasional episodes of gastro-esophageal reflux are common healthy in individuals. Reflux is normally followed by esophageal peristaltic waves that efficiently clear the gullet, alkaline saliva neutralises residual acid and symptoms do not occure. Gastro esophageal reflux disease develops when the esophageal mucosa is exposed to gastroduodenal contents for prolonged periods of time, resulting in symptoms and, in proportion of cases, esophagitis.

     Several factors are known to be involved in development of gastroesophageal reflux disease .  (4)

Ø  Abnormalities of the lower esophageal sphincter

Ø  Gastric contents    

Ø  Delayed esophageal clearance

Ø  Hiatus Hernia     

Ø  Defective gastric emptying  

Ø  Decreased intra -abdominal pressure

Ø  Dietary and environmental factors.     .

Ø  Patient factors 

CLINICAL FEATURES

     The major symptoms are heartburn and regurgitation, often provoked by bending, straining or lying down. ‘Waterbrash’, which is salivation due to reflex salivary gland stimulation as acid enters the gullet, is often present. The patient is often overweight. Some patients are woken at night by choking as refluxed fluid irritates the larynx. Others develop odynophagia or dysphagia. A variety of other features have been described, such as atypical chest pain that may be severe and can mimic angina; it may be due to refluxed induced esophageal spasm. Others include hoarseness (acid laryngitis),  recurrent chest infections, chronic cough, and asthma. The true relationship of these to gastroesophageal reflux disease remains unclear. (4)

INVESTIGATION

     Young patient who present with typical symptoms of gastroesophageal reflux, without  worrying features such as dysphagia, weight loss or anaemia, can be treated empirically without investigation. investigation is advisable if patient present over the age 50-55years ,if symptoms are atypical or if complication is suspected. Endoscopy is the investigation of choice. (4)

 Twenty -four-hour Ph monitoring is indicated if the diagnosis is unclear or surgical intervention is under consideration.  (4)

MANAGEMENT

   Lifestyle advice should be given, including weight loss, avoidance of dietary items that worsen symptoms elevation of the bed head in those who experience nocturnal symptoms, elevation of the bed head in those who experience nocturnal symptoms avoidance of late meals and cessation of smoking, Patients who fail to respond to these measures should be offered PPIs, which are usually effective in resolving symptoms and healing esophagitis. Recurrence of symptoms is common when therapy is stopped and some patient require lifelong treatment at the lowest acceptable dose. When dysmotility feature are prominent, domperidone can be helpful. There is no evidence that H. pylori eradication has any therapeutic value. proprietary antacids and alginates can also provide symptomatic benefit.H2 receptor antagonist drugs relieve symptoms without healing esophagitis.  (4)

Long term PPI therapy is associated with reduced absorption of iron,B12 and magnesium, and a small but increased risk of osteoporosis and fractures. the drug also predispose to enteric infection with Salmonella, Campylobacter and possibly Clostridium difficile, and have recently been shown to have an undesirable impact on the composition of the gut. (4)

     Patient who fail to respond to medical therapy, those who are unwilling to take long term PPIs and those whose major symptom is severe regurgitation should be considered for laparoscopic anti -reflux surgery. (4)

GERD -HRQL SCORRING SCALE

     GERD -related symptoms were evaluated with the GERD-HRQL questionnaire. This validated questionnaire consists of six heartburn -related questions, two swallowing -related questions, one gas bloating questions, two swallowing -related question, one gas bloating question, and one question related to medication use. patient provide a response to each question on scoring scale of 0-5, with higher scores indicating worse symptoms. (7)

 GERD -HRQL Scoring scale

0 -   No symptoms

1 -   Symptoms noticeable but not bothersome

2 -   Symptoms noticeable and bothersome but not every day

3 -   Symptoms bothersome every day.

4-   Symptoms affect daily activities

5 - Symptoms are incapacitating; unable to do activities

 Questionnaire for GERD -HRQL Scale.

1)    How bad is your heartburn?

2)    Heartburn when lying down?

3)    Heartburn when standing up?

4)    Heartburn after meals?

5)    Does heartburn change your diet?

6)    Does heartburn wake you from sleep?

7)    Do you have difficulty in swallowing?

8)    Do you have bloating and gassy feeling?

9)    Do you have pain with swallowing?

10) If you take medication, does this affect your daily life

INDICATION OF NUX VOMICA FROM ALLEN’S KEYNOTES (8)

Constitution-

·       One of the best remedies with which to commence treatment of cases that have been drugged by mixtures, bitters, vegetable pills, nostrum or quack remedies, especially aromatic or “hot medicines,” but only if symptoms correspond.

·       Adapted to thin, irritable, careful, Zealous person with dark hair and bilious or sanguine -temperament. Disposed to be quarrelsome, spiteful, malicious, nervous, and melancholic.

·       Debauchers of thin, irritable, nervous disposition, prone to indigestion and hemorrhoids.

·       “Nux is chiefly successful with person of an ardent character; of an irritable, impatient temperament, disposed to anger, spite or deception.”-Hahnemann.

·       Anxiety with irritability and inclination to commit suicide, but is afraid to die.

·       Hypochondriac literary, studious person ,who are too much at home ,suffer from want of exercise, with gastric abdominal complaint and costiveness; especiallyin drunkards.

 

MENTAL GENERALS -Person who are very particular, careful, but inclined to become easily excited or angered, irascible and tenacious.

 

PHYSICAL GENERALS

·       Bad effects of: Coffee, tobacco, alcoholic stimulants; highly spiced or seasoned food; over -eating; long -continued mental over-exertion; sedentary habits; loss of sleep; aromatic or patent medicine; sitting on cold stones, especially in warm weather.

·       Oversensitive: to external impression; to noise, odors, light or music; trifling ailments are unbearable every harmless word offends.

·       Pains are tingling, sticking, hard, aching, worse from motion ,and contact.

·       Tendency to faint; from odors; in morning; after eating; after every labor pain.

·       Cannot keep from falling asleep in the evening while sitting or reading hours before bedtime, and awake at 3 or 4 a.m.; falls into dreamy sleep at daybreak from which he is hard to arouse, and then feels tired and weak.

GASTRO INTESTINAL SYSTEM

·       Eructation sour, bitter, nausea and vomiting every morning with depression of spirits; after eating.

·       Nausea: Constant; after eating; in morning; from smoking; and feels “If I could only vomit I would be so much better.”

·       Stomach: Pressure an hour or two hour after eating as from a stone; pyrosis, tightness, must  loosen clothing; cannot use the mind for two or three hours after meal; sleepy after dinner; from anxiety, worry, brandy, coffee, drugs, night watching , high living, etc.

·       Constipation; with frequent unsuccessful desire, passing small quantities of feces; sensation as if not finished.

·       Frequent desire for stool; anxious, ineffectual, >for a time after stool; in morning after rising; after mental exertion.

·       Alternate constipation and diarrhea, in persons who have taken purgatives all their lives.

·       Strangulated hernia, especially umbilical.

 

MODALITIES

·       Aggravation: Morning; waking at 4 a.m., mental exertion, after eating or over eating; touch; noise, anger, spices, narcotics, dry weather; in cold air.

·       Amelioration: In evening, while at rest; lying down, and in damp wet weather.

 

INDICATION OF NUX VOMICA FOR GERD FROM CLARKE DICTIONARY OF PRACTICAL MATERIA MEDICA.  (9)

 

Characteristic

·       Spasm and convulsion which cause the death by arresting respiratory movements.

·       “Convulsions with consciousness.”

·       Convulsion with red face and closed eyes.

·       “spasm” is the first keynote of the nux and second is the exaggerated sensitiveness.”

·       The spasm affect the all the voluntary and involuntary muscle of the body.

·       Prolapse of rectum with constipation; or there may be incontinence of both urine and faeces.

·       The irritability  and excessive sensitiveness of the nux depicted in the tetanic seizure and drawn facial expression applies to mind as well as body.

·       Nux is especially suited to

1-    Very particular, zealous person, inclined to get angry and excited, or of a spiteful, malicious disposition.

2-    Ardent person; or, disposed to anger, spite  or deception; always irritable or impatient.

3-    Nervous, melancholic people, troubled with indigestion; venous constitution with tendency to haemorrhoids.

4-    Thin, irritable, choleric persons with dark hair, who make great mental excertion or lead a sedentary life.

5-    Vigorous persons of dry habit, tense fibre, ardent and irascible temperament and tenacious disposition.

6-    Bilious temperament 

7-    Person addicted to wine, coffee, or pepper and condiments, who live a sedentary life with much mental exertion.

8-    Debauchees, thin, irritable, venous.

9-    Drugged subjects.

·       Throughout all these classes moral, mental, nervous, and muscular tension or spasms may be traced.

·       There are many pains in connection with the rectum, constipation or spasm is the leading feature: “constrictive sensation at times as if he would be obliged to go stool.” “after a stool  it seemed as if some remained behind and could not be evacuated, with a sensation of constriction in rectum, not in anus.

·       Discharge of bright blood with the faeces, with sensation of constriction and contraction in rectum during stool.”

·       Stool daily tough always with the a colicky sensation in abdomen,and with the stool, it always seems as if it was not enough.”

·       “frequent in effectual desire for stool; after the usual evacuation.”

·       The diarrhoea the nux is sudden and drives patients out of bed; or is involuntary; or comes on after a meal. Alternate constipation and diarrhoea.

·       In the dysentery of nux the straining ceases as soon as the motion passes.

·       There is tendency  to faint after diarrhroic stool; and also after vomiting. this tendency to fainting is another example of nux sensitiveness.it occurs from odours; in warm room; after eating; after every labour pain.

·       Nux has proved curative in epilepsy when the fit occurred during stool.

·       The pains are cramping and cause nausea and fainting; twisting, moving about in abdomen; soreness across pubes; cramps in bladder.

·       Sexual desire is excited in both sexes, and there again the sensitiveness of nux is observed -the slightest provocation suffices to excite the sexual passion.

·       The third keynote of nux is chilliness. Chilliness from being uncovered.

·       Nux has hunger with aversion to food.

·       Causation – anger, coffee, alcohol, Debauchery, masturbation, sexual exces

§  Frequent and violent hiccough.-they want to belch, but a kind of oesophageal constriction seems to prevent it.

§  Belching of wind, which is difficult.-pyrosis, < after taking acids, or fat food.

§  Continual nausea, and inclination to vomit, <in morning, or during a meal, or after eating or drinking.

§  Constant seek  feeling affecting body here and there.

§  Heartburn – scraped sensation in pit of stomach

§  Waterbrash -empty vomiturition; straining vomit; periodical attacks of the vomiting; of food, of sour – smelling mucus, of dark, clotted blood; and during pregnancy.

§  Retching and violent vomiting of the mucous and sour matter or bile <after having drunk or eaten, or in morning, or else at night, and often with headache

§  Pressure and tension in pit of stomach.

§  Painful sensitiveness in pit of stomach to least pressure ; tight cloths ; are insupportable.

§  Great uneasiness in precordial region, s if heart would burst. Sensation in cardia as if the food were stopped there and returned into oesophagus.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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