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CTRI Number  CTRI/2025/08/092202 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Understanding and Managing Mind Body Illness manifested as somatic complaints with Homoeopathy  
Scientific Title of Study   To study Somatic Symptom Disorder in Economically Productive age group and its Homoeopathic management. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Prathna Mahendra Goplani 
Designation  MD Part 2 
Affiliation  C D Pachchigar college of homoeopathic medicine and hospital 
Address  2nd floor Room number 302 PG Division Department of Psychiatry C D Pachchigar college of homoeopathic medicine and hospital near Navjivan circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9408593686  
Fax    
Email  prathnagoplani411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Yesade 
Designation  Professor of Homoeopathic Psychiatry 
Affiliation  C D Pachchigar college of homoeopathic medicine and hospital 
Address  2nd floor Room number 302 PG Division Department of Psychiatry C D Pachchigar college of homoeopathic medicine and hospital near Navjivan circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti Yesade 
Designation  Professor of Homoeopathic Psychiatry 
Affiliation  C D Pachchigar college of homoeopathic medicine and hospital 
Address  2nd floor Room number 302 PG Division Department of Psychiatry C D Pachchigar college of homoeopathic medicine and hospital near Navjivan circle Udhana Magdalla Road SuratC D Pachchigar college of homoeopathic medicine and hospital near Navjivan circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homeopathic Medicine and Hospital  
 
Primary Sponsor  
Name  C D Pachchigar College od Homoeopathic College and Hospital 
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital 
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 
Prathna Goplani  C D Pachchigar college of Homoeopathic Medicine and Hospital   2nd floor Room number 302 PG Division Department of Psychiatry C D Pachchigar college of homoeopathic medicine and hospital near Navjivan circle Udhana Magdalla Road Surat
Surat
GUJARAT 
9408593686

prathnagoplani411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C D Pachchigar College of Homoeopathic Medicine and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicine  Homoepathic medicines dose, potencies and repetition, via oral route of administration, as per requirement of cases and susceptibility of patient. Duration of intervention would be within 9 months. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Subjects who meet DSM 5 TR criteria for Somatic Symptom Disorder.
Economical class: Patients of all economical class would be included.
Patients with any other psychiatric comorbidity will be included. 
 
ExclusionCriteria 
Details  Below 25 and above 55 year of age group is excluded.
Patients with delusional disorders.
Patients who are non-compliant.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Homoeopathic medicines has an effect on Somatic Symptom Disorder in adults of 25 to 55 years age group   6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
to understand the precipitating psychological factors in somatic complaints.   6 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)   04/08/2025 
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="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

BRIEF RESUME OF INTENDED WORK:

6.1

NEED FOR STUDY:

-       About 25-30% of patients present themselves in general practice and specialized healthcare with medically unexplained somatic symptoms. The prevalence of these symptoms is the highest among the elderly, children and adolescents. (1) Somatization disorder most frequently occur with symptoms of headache, stomach ache or various kinds of pain in the limbs that show high comorbidity with other mental disorders, predominantly with anxiety. SSDs are always multi causal issues where biological, social, environmental and psychological factors are interconnected in a complex manner.  (1) 

-       Somatisation is one of the commonest psychiatric disorders in the community, although its prevalence has been difficult to measure. (2)

-       We know that many symptoms (around 30%) presenting to General Practitioners do not have a cause identified. Many of these resolve within a few weeks, but some persist up to 5 years or more. The WHO study found that patients with five or more somatic symptoms had significantly increased morbidity and physical disability at follow-up, with little difference in outcome between patients with medically explained and unexplained symptoms. Thus, although finding or excluding organic disease is important, it is not the end of the story.  (2)

-       Somatic symptoms are a frequent presentation of distress in general practice, and up to 30% of common somatic symptoms go undiagnosed. One of the interesting issues in somatisation is its relationship with depression and anxiety. In some patients the distress is “converted” successfully to somatic symptoms and concern, and emotional distress is low; in others the somatic symptoms are part of a general distress syndrome best characterised by depression and anxiety. Somatisation does significantly reduce the likelihood of General practitioners recognising depression or anxiety.  (2)

-       Somatic Symptom Disorder (SSD) is a new disorder defined in the Diagnostic and Statistical Manual Fifth Edition (DSM-5), replacing somatoform and related disorders in the DSM-4 Text Revision with diagnostic criteria that are inclusive of a broad array of presentations.  (3)The DSM-5 also removed somatization disorder, undifferentiated somatoform disorder, hypochondriasis, and pain disorder. Many patients that historically met the criteria for one of those conditions now meet criteria for SSD, based on these revisions. (4)

6.2

REVIEW OF LITRATURE:


INTRODUCTION

-       Somatic symptom disorder (SSD) involves one or more physical symptoms accompanied by an excessive amount of time, energy, emotion, and/or behaviour related to the symptom that results in significant distress and/or dysfunction. Physical symptoms may or may or may not be explained by a medical condition. In previous editions of the Diagnostic and Statistical Manual of Mental Disorders, the diagnosis of somatic symptom disorder could not be made unless somatic symptoms were not able to be explained clinically. Additionally, previous editions did not include the requirement that certain psychobehavioral features be present for the diagnosis of somatic symptom disorder to be made. (4)

-       The symptoms may or may not be associated with another medical condition. The diagnosis of somatic symptom disorder and a concurrent medical illness are not mutually exclusive, and these frequently occur together.  (5)

-       The course of somatic symptom disorder is likely to be chronic and fluctuating and influenced by the number of symptoms, individual’s  age, level of impairment, and any comorbidity. The course is also influenced by personality traits, with less harm avoidance and greater cooperativeness associated with a shorter time to remission. (5)

-       In the International Classification of Diseases, 11th Revision (ICD-11), Somatic Symptom Disorder is classified under 6C20: Bodily Distress Disorder.  (6)

CLINICAL FEATURES AND DIAGNOSTIC CRITERIA: 

-       Individuals with somatic symptom disorder typically have multiple, current, somatic symptoms that are distressing or result in significant disruption of daily life, although sometimes only one severe symptom, most commonly pain, is present. The symptoms sometimes represent normal bodily sensations or discomfort that does not generally signify serious disease. The individual’s suffering is authentic, whether or not it is medically explained.  (5)

-       Individuals with somatic symptom disorder tend to have very high levels of worry about illness. They appraise their bodily symptoms as unduly threatening, harmful, or troublesome and often think the worst about their health. (5)

-       The diagnostic criteria according to DSM 5-TR  [DIAGNOSTIC AND STATISTICAL MANUAL FIFTH EDITION] is as follows:  (5)

     A. One or more somatic symptoms that are distressing or result in significant disruption of daily life. 

     B. Excessive thoughts, feelings, or behaviors related to the somatic symptoms or associated health concerns as manifested by at least one of the following: 

           1. Disproportionate and persistent thoughts about the seriousness of one’s symptoms. 

           2. Persistently high level of anxiety about health or symptoms. 

           3. Excessive time and energy devoted to these symptoms or health concerns. 

Specify if:

            With predominant pain (previously pain disorder): This specifier is for individuals whose somatic symptoms predominantly involve pain. 

Although any one somatic symptom may not be continuously present, the state of being symptomatic is persistent (typically more than 6 months). 

      Specify if:

  Persistent: A persistent course is characterized by severe symptoms, marked impairment, and long duration (more than 6 months). 

Specify current severity: 

     Mild: Only one of the symptoms specified in Criterion B is fulfilled.

    Moderate: Two or more of the symptoms specified in Criterion B are fulfilled. 

    Severe: Two or more of the symptoms specified in Criterion B are fulfilled, plus there are multiple somatic complaints (or one very severe somatic symptom). 

 

ETIOLOGY:

-       Persons with this disorder augment and amplify their somatic sensations; they have low thresholds for, and low tolerance of, physical discomfort. (7)

-       The psychodynamic school of thought holds that aggressive and

hostile wishes toward others are transferred (through repression and displacement) into physical complaints. The anger of patients with this disorder originates in past disappointments, rejections, and losses, but the patients express their anger in the present by soliciting the help and concern of other persons and then rejecting them as ineffective. (7)

-       This disorder is also viewed as a defense against guilt, a sense of innate badness, an expression of low self-esteem, and a sign of excessive self-concern. Pain and somatic suffering thus become means of atonement and expiation (undoing) and can be experienced as deserved punishment for past wrongdoing (either real or imaginary) and for a person’s sense of wicked ness and sinfulness. (8)

-                Association between somatic symptoms and psychological distress:  From the psychoanalytic perspective, somatisation is “a conversion of emotional stress into somatic stress”. This is confirmed in a study where 66% of participants attributed psychological distress or a combination of psychological and physical problems as the source of their somatic complaints. Also, showed that almost 60% of patients with anxiety or depression reported greater somatisation than 29.6% of those with somatisation reporting increased anxiety or depression. This imply that somatisation and psychological distress may have a reciprocal influence on each other, with the latter having a greater influence on the former.  (9)

 

DIFFERENTIAL DIAGNOSIS:  (8)

      Somatic symptom disorder must be differentiated from non-psychiatric medical conditions before making a psychiatric diagnosis. Some psychiatric disorders that need to be differentiated are: 

-       Illness anxiety disorder,

-       Conversion disorder

-       Factitious disorder

-       Body dysmorphic disorder

-       Delusional disorder

 

 HOMOEOPATHIC APPROACH 

Mental diseases of Somatopsychic type (§215): The diseases that arise after the decline of the corporeal symptoms thereby increasing the symptoms of the derangement of the mind and disposition that attains the most one sidedness. (10)

Once the symptoms of the previous disease has been collected, these can be mixed with the existing corporeal and mental symptoms. Thus, the totality is formed. To this complete picture of the disease, the medicine capable of producing strikingly similar (especially to the mental symptoms) have to be selected. The final remedy must be an anti-psoric one, which will complete the cure. (§217-220)

Mental diseases of Psychosomatic type (§225): Mental diseases that arise as a result of prolonged emotional disturbances and different psychological depressions like continued anxiety, worry, vexation, wrongs and frequent occurrence of greater fear and fright. Such diseases may be of recent origin and may not have developed fully into corporeal diseases. But if left untreated they may damage the body. (10)

Such mental diseases of psychic origin can be treated by means of psychological remedies like confidence building, friendly exhortations, sensible advice and a well disguised deception. This has to be always supported by good diet and regimen. Radical anti-psoric treatment has to be given to avoid any type of recurrences. (§ 226-227)

According to § 215-216 Hahnemann considers mental disease as one sided diseases of the chronic type affecting the whole psychosomatic entity.  (10)

Common suitable homeopathic drugs for Somatic symptom disorder:  (11)

-       Anacardium, Argentum nitricum, Arsenicum album, Asafoetida, Belladonna, Cannabis indica, Cocculus, Gelsemium, Ignatia, Kali phosphoricum, Moschus, Nux moschata, Platina, Pulsatilla, Tarentula, Valeriana, etc.

6.3

OBJECTIVES OF STUDY

 

1.     To understand Somatic Symptom Disorder in adults of 25 to 55 years age group and its Homoeopathic Management.

 

2.     2.  To understand the precipitating psychological factors in somatic complaints.

7

MATERIALS AND METHODS

7.1

SOURCE OF DATA

 

·      O.P.D of C.D. PACHCHIGAR Homoeopathic college & hospital.

·      Peripheral centre, and regular camp visit of C.D. PACHCHIGAR Homeopathic medical college & hospital.

·      Data will be collected via interview processes, this process includes guidelines mentioned in the organon of medicine, and case-taking will be done with reference to aphorisms number 83 to 104 as explained by Dr. Samuel Hahnemann.

7.2

MATERIAL:

Textbooks of Psychiatry, Book of organon of medicine, philosophy, Materia medica, repertory, all homoeopathic books & literature related to topic, software & soft or hard research material.

7.3

METHOD OF COLLECTION OF DATA:

 

1.    Study type: Experimental study

 

2.    Study design: Prospective study

 

3.    Study population: patients from OPD of C. D. Pachchigar Homoeopathic Hospital and from peripheral OPDs.

 

4.    Sample size: 30 patients.

 

5.    Sampling techniques: Non-Probability Purposive sampling.

 

6.    Study duration: 9 months.

 

7.    Selection criteria:

 

v Inclusion criteria:

 

-  Patient covering DSM-5 criteria for somatic symptom disorder.

-  Patient of 25 to 55 year age group.

-  Both sexes will be included.

-  Economical class: Patients of all economical class would be included.

- Patients with any other psychiatric comorbidity.

 

v Exclusion criteria:

 

- Below 25 and above 55 year of age group is excluded.

- Patients with delusional disorders.

- Patients who are non-compliant.

 

v Data analysis and methods:

 

- Scale of study: PHQ-15 [Patient Health Questionnaire – 15]

- Improved: Subjects showing a clinically marked decreased in the score of respective scale with a decrease in the intensity of the somatic symptom/s.

- Not Improved: No clinically favourable improvement after medicinal interventions. Adults with aggravated scores in their respective scoring scales.

- Left the treatment: Subjects who will not maintain regular follow-ups till advised to discontinue treatment.

7.4

DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

The diagnosis of the case will be done on the basis of the case history and

clinical findings. Special investigations will be done as and when required.

7.5

HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTE?

YES

8

Bibliography

1.

Réka Borbála Tamás DPFOMaZG. [Online]. Available from: http://akjournals.com/view/journals/650/161/25/article-p1050.xml.

2.

David M Clarke LPCJBaDWA. [Online]. Available from: https://www.mja.com.au/journal/2008/189/10/somatic-symptoms-hypochondriasis-and-psychological-distress-study-somatisation.

3.

Rosic T KSSZ. [Online]. Available from: https://casereports.bmj.com/content/2016/bcr-2015-212553.

4.

D’Souza RS, Hooten WM. [Online]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532253/.

5.

Association AP. Diagnostic and Statistical Manual of Mental Disorders. 5th ed.: American Psychiatric Association Publishing ; 2022.

6.

Organisation WH. International Classification of Diseases 11th Revision. 12th ed.: Geneva World Health Organisation; 2022.

7.

Sadock VA RP,SB. Kaplan and Sadock’s Comprehensive Textbook of Psychiatry. 10th ed.: Philadelphia Wolters Kluwer; 2017.

8.

R J. Kaplan & Sadock’s synopsis of Psychiatry. 12th ed.: Philadelphia: Wolters Kluwer; 2021.

9.

Babatola Dominic Olawa, Erhabor Sunday Idemudia, Benjamin Oluwabunmi Omolayo, and Judith Chinneye Azikiwe. [Online]. Available from: https://journals.sagepub.com/doi/epub/10.1177/20551029231206764.

10.

S. H. Organon of Medicine. 6th ed. New Delhi: B. Jain Publishers; 2016.

11.

W. B. Boericke’s Materia Medica with Repertory New delhi: B. Jain Publishers; 2007.


 
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