| CTRI Number |
CTRI/2025/07/091217 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on how homoeopathy affects thyroid hormone (TSH) levels in Hypothyroid patients |
|
Scientific Title of Study
|
Assessing the efficacy of individualised homoeopathic remedies on the TSH levels and Billewicz scale in the treatment of hypothyroidism cases: A randomized controlled trial. |
| 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 Thrupthi S |
| Designation |
Associate professor |
| Affiliation |
BVVS Homeopathic Medical College and Hospital. |
| Address |
Department of physiology and Biochemistry,
1st floor,
BVVS Homeopathic Medical College and Hospital,
Bagalkot.
Bagalkot
KARNATAKA
587101
India |
| Phone |
7619339184 |
| Fax |
|
| Email |
thrupthikadabadi400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas L Patil |
| Designation |
Professor and Guide |
| Affiliation |
SJPESs Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine. Ground Floor,
SJPESs Homoeopathic Medical College and Hospital,
200, E, Tararani Chowk
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9421288470 |
| Fax |
|
| Email |
suhas_20august@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thrupthi S |
| Designation |
Associate professor |
| Affiliation |
BVVS Homeopathic Medical College and Hospital. |
| Address |
Department of physiology and Biochemistry,
1st floor,
BVVS Homeopathic Medical College and Hospital,
Bagalkot.
Bagalkot
KARNATAKA
587101
India |
| Phone |
7619339184 |
| Fax |
|
| Email |
thrupthikadabadi400@gmail.com |
|
|
Source of Monetary or Material Support
|
| SJPESs Homoeopathic Medical College and Hospital,
200 E, Tararani Chowk, Kawala Nakap,
Kolhapur, Maharashtra, India
PinCode-416003 |
|
|
Primary Sponsor
|
| Name |
Dr Thrupth S |
| Address |
Department of physiology and Biochemistry,
1st floor,
BVVS Homeopathic Medical College and Hospital,
Bagalkot. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr ThrupthiS |
SJPEs Homeopathic Medical College and Hospital, |
Department of Organon of Medicine, Ground floor, OPD No. 1
200, E, Tararani Chowk, Kawala Naka, Maharashtra, India
Kolhapur
MAHARASHTRA |
7619339184
thrupthikadabadi400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Indicated homoeopathic medicine with Levothyroxine. |
1) Indicated homoeopathic medicine- Orally, 6 pills OD for 2 days, followed by Sac Lac- 6 pills/ BD for 15 days.
Levothyroxine- 1 table orally OD daily
Duration- 1 Year |
| Comparator Agent |
Placebo with Levothyroxine. |
Placebo- Orally, 6 pills OD for 2 days, followed by Sac Lac- 6 pills/ BD for 15 days. Levothyroxine- 1 table orally OD daily
Duration- 1 Year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who provide informed consent, regardless of their socio-economic status, religion, or occupation.
2. Subjects diagnosed with hypothyroidism within the past one year, having a TSH level greater than 5.0 micro-IU per mL, and currently receiving Levothyroxine therapy.
3. Subjects with a Body Mass Index ranging between 18.5 and 24.9 kg per m².
|
|
| ExclusionCriteria |
| Details |
1. Subjects diagnosed with secondary hypothyroidism.
2. Subjects with known chronic systemic illnesses, such as diabetes mellitus, hypertension, or polycystic ovarian syndrome, are currently undergoing active treatment.
3. Expectant mothers, pregnant women, and lactating mothers.
4. Subjects presenting with complications of hypothyroidism, including myxoedema coma or cardiovascular disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be based on the changes in the TSH levels, T3 and T4 levels and Billewicz scoring index. |
baseline thereafter end of every 6th month for 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to assess the effectiveness of individualized homoeopathic remedies in improving thyroid function in patients diagnosed with hypothyroidism. Hypothyroidism is a common condition where the thyroid gland fails to produce sufficient thyroid hormones, leading to symptoms such as tiredness, weight gain, dry skin, and depression. While conventional treatment with Levothyroxine is the standard, it often requires lifelong use and may cause side effects.
In this randomized controlled trial, 80 participants between the ages of 18 and 50, recently diagnosed with hypothyroidism and already receiving Levothyroxine, were divided into two groups. One group received individualized homoeopathic medicines along with Levothyroxine (Group A), while the other received a placebo alongside Levothyroxine (Group B). The participants were monitored over a period of time using two key outcome measures: the levels of Thyroid Stimulating Hormone (TSH) in the blood, and clinical assessment using the Billewicz scoring system, a standardized tool to evaluate hypothyroidism symptoms.
The study seeks to explore whether individualized homoeopathic treatment can contribute to better management of hypothyroidism by reducing TSH levels and improving clinical symptoms, thereby offering a gentler, more holistic approach alongside conventional care. |