| CTRI Number |
CTRI/2026/01/100773 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic Medicine on early stage of thyroid disorder. |
|
Scientific Title of Study
|
Randomized Controlled Trial on effect of Takrarishta in Subclinical 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 |
Sunil Gunderao Solanke |
| Designation |
PhD Scholar |
| Affiliation |
PMTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon |
| Address |
OPD of Kayachikitsa, PMTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7738339314 |
| Fax |
|
| Email |
sunilsolanke6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Gunderao Solanke |
| Designation |
PhD Scholar |
| Affiliation |
PMTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon |
| Address |
OPD of Kayachikitsa, PMTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7738339314 |
| Fax |
|
| Email |
sunilsolanke6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhagwat T Shinde |
| Designation |
Professor |
| Affiliation |
MTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon |
| Address |
OPD of Kayachikitsa, PMTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9922709070 |
| Fax |
|
| Email |
sbhagwat.2007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| OPD of Kayachikitsa,Department of Kayachikitsa, Siddhakala Ayurved College and Hospital,Pimparne road, Sangamner, Ahilyanagar district
Pin code- 422605
State- Maharashtra
Country- India |
|
|
Primary Sponsor
|
| Name |
Sunil Gunderao Solanke |
| Address |
PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmednagar , Maharashtra. |
| 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 |
| Sunil Gunderao Solanke |
Siddhakala Ayurved College, Sangamner |
Department of Kayachikitsa, OPD no.1.
Ahmadnagar
MAHARASHTRA |
7738339314
sunilsolanke6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PMTs Ayurved College Shevagaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: AGNIVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Takrarishta, Reference: CharakSamhita Chikitsasthan 15/120-121, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Levothyroxine | Drug- Tab Levothyroxine
Dose - 25 mcg , Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients having Serum TSH level between 4 to 20 mIU/L.
ii) Patients having Serum T3 and Serum T4 level within normal range.
iii) Patients who are willing to participate in study. |
|
| ExclusionCriteria |
| Details |
i) Patients with MI, Stroke, Cardio Vascular surgery or major operations within 6 months prior to screening visit.
ii) Patients having TSH level more than 20 mIU/L or having symptoms of Myxoedema.
iii) Patient with previous radiation treatment of the thyroid gland.
iv) Women who are pregnant or have a plan to become pregnant in the near future.
v) Patient suffering from uncontrolled DM or uncontrolled Hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i)To decrease the serum TSH level in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days. |
0 day ( 1st visit), 30th day ( 1st follow up) 60th day ( last follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i)To decrease body weight and Body Mass Index in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days.
ii) To decrease clinical features (if any) in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days. |
0 day ( 1st visit), 30th day ( 1st follow up) 60th day ( last follow up) |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
20/01/2026 |
| 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="2"
Months="0"
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
|
Subclinical hypothyroidism (also known as
compensated hypothyroidism or mild hypothyroidism) is a condition associated
with a raised serum concentration of thyroid stimulating hormone (TSH) but a
normal serum free thyroxine (FT4). It is common, affecting about 10% of women above
the age of 55 years.
Autoimmunity is the commonest cause of subclinical hypothyroidism. About 2.5%
of patients with subclinical hypothyroidism progress to clinically overt
hypothyroidism each year; the rate of progression is higher in patients with
thyroid autoantibodies and higher thyroid stimulating hormone levels. However,
thyroid function normalises spontaneously in up to 40% cases. Only a small
minority of patients with subclinical hypothyroidism have symptoms, and the
evidence to support that levothyroxine ameliorate the symptoms in these
patients is weak.
In Ayurveda there is no
direct comparison regarding Subclinical Hypothyroidism but on the basis of
clinical presentation it can be correlated with Agnimandya. In Ayurved, Charak has mentioned
different types of Agni and Functions of Prakrit Agni
in Grahani Chikitsa Adhyaya. He also mentioned the types
of Vikrit Agni and their effects in body. Under that he stated
the clinical features of the Agnimandya. Various treatment in the form
of Panchakarma and Kalpa i.e. oral medications are given. This study is taken to evaluate the effect of
Takrarishta in the Subclinical Hypothyroidism with respect to Agnimandya. |