| CTRI Number |
CTRI/2025/12/099279 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effect of a Plant-Based Nutraceutical on Thyroid Function in reducing dose of levothyroxine for primary hypothyroidism. |
|
Scientific Title of Study
|
A Randomized, Parallel Arm Trial Evaluating Thyphy as an Adjunct Intervention for Maintaining Euthyroid Status During Levothyroxine Tapering |
| 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 Ragavendra Pandilwar |
| Designation |
Associate Professor |
| Affiliation |
Dr. G. D. POL Foundation Y. M. T. Ayurvedic Medical College and Hospital |
| Address |
Dr.G.D.POL FOUNDATION Y.M.T.Ayurvedic Medical college and HospitalPG INSTITUTE Institutional Area ,sector 4 Kharghar Navi Mumbai410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9699365567 |
| Fax |
|
| Email |
raghavendra.pandilwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shefali Thakkar |
| Designation |
Head- Research and Product Development |
| Affiliation |
Arelang Naturals Pvt. Ltd. |
| Address |
28, Raghuvanshi Mills Compound, Senapati Bapat Marg,
Lower Parel,
Mumbai 400013
Mumbai
MAHARASHTRA
400013
India |
| Phone |
8879350005 |
| Fax |
|
| Email |
shefali@arelang.com |
|
Details of Contact Person
Public Query
|
| Name |
Shefali Thakkar |
| Designation |
Head- Research and Product Development |
| Affiliation |
Arelang Naturals Pvt. Ltd. |
| Address |
28, Raghuvanshi Mills Compound, Senapati Bapat Marg,
Lower Parel,
Mumbai 400013
Mumbai
MAHARASHTRA
400013
India |
| Phone |
8879350005 |
| Fax |
|
| Email |
shefali@arelang.com |
|
|
Source of Monetary or Material Support
|
| Arelang Naturals Pvt. Ltd.
28, Raghuvanshi Mills Compound Senapati Bapat Marg, Lower Parel, Mumbai 400013 |
|
|
Primary Sponsor
|
| Name |
Arelang Naturals Private Limited |
| Address |
28, Raghuvanshi Mills Compound Senapati Bapat Marg,
Lower Parel,
Mumbai 400013 |
| Type of Sponsor |
Other [Private Nutraceutical Company] |
|
|
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 Raghavendra Pandilwar |
Dr. G. D. POL Foundation Y. M. T. Ayurvedic Medical College and Hospital |
Thyroid Speciality OPD,
Consultation Room no -08,
Institutional Area Sector 4,
Kharghar,
NaviMumbai 410210
Raigarh
MAHARASHTRA
Mumbai
MAHARASHTRA |
9699365567
raghavendra.pandilwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Research Dr.G.D.POL FOUNDATION Y.M.T.Ayurvedic Medical college and Hospital PG INSTITUTE |
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 |
| Comparator Agent |
LevoThyroxine with Dose less than or equal to 50 mcg |
Both groups will consume Levothyroxine alongwith
Thyroxine medication empty stomach every morning |
| Intervention |
ThyPhy for Balance |
Both Groups will consume ThyPhy for Balance alongwith
Thyroxine medication empty stomach every morning for a period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female adults aged 18–65 years.
Clinical diagnosis of primary hypothyroidism on stable levothyroxine replacement for less than equal to 6 months with no dose change in the last 3 months.
Current levothyroxine dose not more than 50 µg/day (NMT 50 µg) at screening.
Biochemically euthyroid at screening: TSH within local lab reference range and free T4 within reference range (drawn on stable dose).
Willingness to start and adhere to ThyPhy for Balance dosing regimen and to follow the taper schedule.
Able to give written informed consent and comply with study procedures and follow-up.
If female and of childbearing potential: negative pregnancy test at screening and agreement to use reliable contraception for study duration. |
|
| ExclusionCriteria |
| Details |
Overt Hypothyroidism
Patient taking thyroxine dosages more than 50 mcg
History of thyroid surgery or radioactive iodine treatment
Uncontrolled chronic diseases (e.g., uncontrolled diabetes, cardiovascular disorders, renal or hepatic impairment)
Pregnant or lactating women
Diagnosed psychiatric or neurological conditions interfering with study compliance
History of allergy to any components of the investigational product
Participation in another clinical trial within the last 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maintenance of Euthyroid Status in participants during Levothyroxine tapering by measuring TSH, FT3 & FT4.
Laboratory Parameters like Serum TSH, FT3 & FT4 within laboratory reference range without the need for rescue escalation of levothyroxine dose. |
Day 0, 30, 60 & 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the subjective criteria which includes: Weight gain, Lethargy & Fatigue, Constipation, Puffiness of Face,Amenorrhea, Hair loss, Skin Dryness, Hoarseness of voice, Cold Intolerance, Slowed Movement, Difficulty concentration and poor memory |
Day 0, 30, 60 & 90 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/12/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Hypothyroidism is commonly treated with lifelong levothyroxine therapy. However, a subset of patients maintained on low doses of levothyroxine may be able to sustain normal thyroid function with appropriate supportive interventions. This Phase-2, single-arm clinical study aims to evaluate the effectiveness and safety of ThyPhy for Balance, a plant-based nutritional intervention, in maintaining euthyroid status during a structured tapering of levothyroxine leading to reversal of hypothyrodism.
Adult patients with primary hypothyroidism who are clinically and biochemically euthyroid on a stable levothyroxine dose of not more than 50 mcg/day will be enrolled. Participants will undergo a stepwise reduction of levothyroxine over a period of 3 months (90 days) while receiving ThyPhy for Balance as an adjunct intervention. Thyroid function will be closely monitored throughout the study.
The primary outcome of the study is the proportion of participants who maintain biochemical euthyroidism (normal TSH and free T4 levels) at the end of the tapering period. Secondary outcomes include the extent of levothyroxine dose reduction achieved, changes in thyroid hormone parameters, symptom burden, quality of life, and safety outcomes.
This study is designed to generate proof-of-concept evidence on whether ThyPhy for Balance can support endogenous thyroid function and reduce dependency on exogenous levothyroxine in patients leading to reversal of hypothyroidism. |