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CTRI Number  CTRI/2025/07/091438 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   How Homoeopathy Helps In The Treatment Of Cases of Hypothyroidism 
Scientific Title of Study   Utility of Homoeopathy in cases of Hypothyroidism 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Heema Jayeshbhai Shani 
Designation  PG Scholar 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India 
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital Post Graduation Division Department of Practice of Medicine 2nd floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India

Surat
GUJARAT
395001
India 
Phone  8320986884  
Fax    
Email  heemashani137@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer S Upadhyay 
Designation  M D HOM.  
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India 
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital Post Graduation Division Department of Practice of Medicine 2nd floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India

Surat
GUJARAT
395001
India 
Phone  9426836991  
Fax    
Email  drsameerupadhyay@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sameer S Upadhyay 
Designation  M D HOM.  
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India 
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital Post Graduation Division Department of Practice of Medicine 2nd floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India

Surat
GUJARAT
395001
India 
Phone  9426836991  
Fax    
Email  drsameerupadhyay@rediffmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India 
 
Primary Sponsor  
Name  C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India 
Address  C D Pachchigar College of Homoeopathic Medicine and Hospital Post Graduation Division Department of Practice of Medicine 2nd floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat 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 
Heema Jayeshbhai Shani  C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India  C D Pachchigar College of Homoeopathic Medicine and Hospital Post Graduation Division Department of Practice of Medicine 2nd floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India
Surat
GUJARAT 
08320986884

heemashani137@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee Of C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Individualized Homoeopathic Medicine Will Be Prescribed On The Basis Of Totality Of Symptoms And Individual Susceptibility The medicine Will Be Administered In The Form Of Medicated Globules 4 to 6 Globules Per Day The Intervention Will Be 15 To 30 Days 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient from both the sex all socioeconomic class and all age group years will be included
Pre diagnosed cases of hypothyroidism as well as fresh cases
Cases which are diagnosed clinically according to history and sign and symptoms
Diagnosis is done by T3 T4 TSH AntiTPO 
 
ExclusionCriteria 
Details  Critical emergency patient
Cases with advanced pathology and having complications of hypothyroidism
Co-existing severe systemic illness and malignancy
Cases with irregular follow up and those patient who left treatment in between
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Access the Improvement in thyroid profile parameters TSH, T3, T4 levels, Anti TPO level After Individualized Homoeopathic Medicine in Cases of Hypothyroidism  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study Hypothyroidism etiology clinical presentation and management medicinal and lifestyle management  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)   01/08/2025 
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 the Study

The thyroid gland produces two key hormones: thyroxine (T4) and triiodothyronine (T3). Autoimmune thyroid disorders can lead to glandular destruction and hormone deficiency, resulting in hypothyroidism. If untreated, it can cause serious complications.

In India, hypothyroidism is frequently encountered in homeopathic practice. The prevalence of primary hypothyroidism is about 1 in 100, increasing to 5 in 100 when subclinical cases are included. Women are more commonly affected, with a female-to-male ratio of 6 to 1.

Homeopathy has a significant role in the management of thyroid disorders. Remedies influence the hypothalamic-pituitary axis and modulate immune responses. This helps normalize the levels of T3, T4, and TSH, thereby improving thyroid function.

This study aims to improve patients’ mental, physical, and social wellbeing, and to reduce dependency on lifelong hormone replacement therapy. While many patients respond positively to homeopathy, there is a lack of strong research evidence. Hence, this study aims to evaluate the efficacy of homeopathic medicines in managing hypothyroidism.

6.2 Review of Literature

Introduction

Primary hypothyroidism, accounting for 99 percent of cases, is due to thyroid gland dysfunction. Congenital hypothyroidism may present subtly at birth and can lead to neurological damage if untreated. Autoimmune hypothyroidism may present with or without goiter and often starts as subclinical hypothyroidism.

Prevalence

The prevalence of hypothyroidism in India is about 11 percent, with higher rates in females (15.86 percent) and older adults (13.11 percent). Inland areas report more cases than coastal regions. Subclinical hypothyroidism and anti-TPO antibody positivity are also common.

Types of Hypothyroidism

  1. Primary – Thyroid gland dysfunction

  2. Secondary – Pituitary gland dysfunction

  3. Tertiary – Hypothalamic dysfunction
    Secondary and tertiary types are grouped as central hypothyroidism.

Etiology

  • Acquired: Hashimoto’s thyroiditis, iodine deficiency, goitrogen exposure, antithyroid drugs

  • Congenital: Thyroid agenesis, dysplasia, hormone synthesis defects

  • Central: Tumors, hemorrhage, TSH deficiency

  • Resistance to thyroid hormones

Pathogenesis

  • Genetic Factors: HLA polymorphisms, CLTA-4 gene, Down and Turner syndrome associations

  • Environmental Factors: High iodine intake, low selenium, smoking cessation, reduced microbial exposure

Clinical Features

  • General: Fatigue, weight gain, cold intolerance, goiter, hyperlipidemia

  • Skin: Dry skin, puffiness, myxedema, alopecia, vitiligo

  • Neuromuscular: Muscle aches, hoarseness, cerebellar ataxia

  • Gastrointestinal: Constipation, ileus

  • Hematological: Iron deficiency anemia

  • Cardiovascular: Bradycardia, effusions

  • Psychological: Depression, psychosis

Complications

  • Cardiovascular disease

  • Goiter

  • Renal dysfunction

  • Nerve damage

  • Pregnancy-related issues

  • Infertility

  • Myxedema coma

Investigations

  • Thyroid Function Tests: TSH, T3, T4

  • Anti-TPO, Anti-TG Antibodies

  • Serum cholesterol

  • ECG for cardiac changes

Management

  • Conventional: Levothyroxine is the treatment of choice, dosage adjusted based on age, severity, and pregnancy. Regular monitoring is essential. Subclinical cases may be monitored or treated based on associated risk factors.

Homeopathic Approach

According to homeopathic principles (Organon of Medicine), the totality of symptoms, patient constitution, miasmatic background, mental and emotional state, and lifestyle must be considered.

  • Aphorism 5: Identifying exciting and fundamental causes

  • Aphorism 153: Emphasis on striking, peculiar, and characteristic symptoms

  • Aphorism 261: Importance of regimen including lifestyle, exercise, and diet

Indicated Remedies

  • Thyroidinum: For obesity, myxedema, hair loss, and puffiness

  • Iodum: For emaciation with ravenous appetite and goiter

  • Lycopodium: For flatulence, low self-esteem, and impotence

  • Graphites: For delayed menses, constipation, and skin issues

  • Natrum Muriaticum: For salt cravings, dryness, and emotional suppression

  • Sepia: For indifference, bearing-down pains, and menstrual issues

  • Calcarea Carbonica: For cold, flabby, obese patients with slow development

  • Phytolacca: For glandular swellings and a lump sensation in the throat

  • Bromium: For hard glandular swellings and goiter in scrofulous children

 
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