| 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
|
|
|
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
|
|
|
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
-
Primary – Thyroid gland dysfunction
-
Secondary – Pituitary gland dysfunction
-
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
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Neuromuscular: Muscle aches, hoarseness, cerebellar ataxia
-
Gastrointestinal: Constipation, ileus
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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
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Aphorism 153: Emphasis on striking, peculiar, and characteristic symptoms
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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 |