| CTRI Number |
CTRI/2026/01/100133 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Evaluation of Kanchanar Shunti Ghanvati in the Managementof Hypothyroidism |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Study Effect of Kanchnar Shunti Ghanvati and Thyroxine 25 MCG in patients of Primary 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 |
Dr Mayuri Sunil Patil |
| Designation |
Associate professor |
| Affiliation |
SHREE SAPTASHRUNGI AYURVED MAHAVIDYALAY |
| Address |
Department of Kayachikitsa ,Shree Saptashrungi Ayurved Mahavidyalay, Kamal nagar,Hirawadi ,Panchvati,Nashik 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
8668549430 |
| Fax |
|
| Email |
dr.mayuripawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Popat Jagtap |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay |
| Address |
Department of Kayachikitsa ,Shree Saptashrungi Ayurved Mahavidyalay ,Kamal nagar,Hirawadi,Pachvati Nashik 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Popat Jagtap |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay |
| Address |
Department of Kayachikitsa ,Shree Saptashrungi Ayurved Mahavidyalay ,Kamal nagar,Hirawadi,Pachvati Nashik 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mayuri Sunil Patil |
| Address |
Department of Kayachikitsa ,Shree Saptashrungi Ayurved Mahavidyalay, Kamal nagar,Hirawadi ,Panchvati,Nashik 420003 |
| 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 Mayuri Sunil Patil |
Shree Saptashrugi Ayurveda MahavidhyalaDYALAY |
Department of Kayachikitsa ,Shree Saptashrungi Ayurved Mahavidyalay,Hirawadi ,Panchvati,Nashik 420003
Nashik
MAHARASHTRA |
08668549430
dr.mayuripawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAPTASHRUNGI AYURVED COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kanchnar shunthi ghanvati, Reference: bhaishajya ratnawali 44/14, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | TAB LEVOTHYROXINE | DRUG - TAB LEVOTHYROXINE OD
DOSE- 1MCG/KG
ROUTE OF ADMINISTRATION-ORAL
TIME-MORNING BEFORE MEAL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)patient fullfilling the laboratory diagnosis of hypothyroidism on the basis of serum TSH ,T3 and T4 levels
2)patients having TSH level less than 10 mlU/l
3)patients having uncontrolled TSH level in spite of adequate doses of levothyroxine
4)patients having signs and symptoms of hypothyroidism . |
|
| ExclusionCriteria |
| Details |
1) patiet with ischemic heart diasease ,uncontrolled hypertension,myocardial infraction,cerebrovascular event, cardiac arrthmias,pregnancy and active malignant diasease were excluded.
2)patient with altered thyroid harmone levels due to other conditions such as under nutrition,malignant neoplasm or nonthyroidal illness (low t3 syndrome)
3) patient havinh TSH level greater than 10 mlU/l
4) recent thyroid surgery within 12 months
5) patient suffering from diasease like HIV,TB,Encephalopathy,Goitre,other endocrine disorders, and other auto immune disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)to assess the changes in subjective and objective parameters of hypothyroidism with the effect of kanchnar shunthi vati after treatment.
2) to assess the changes in subjective and objective criteria
assessment of objective parameters
1)TSH LEVELS
2)Weight |
Time period will be 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2/ Phase 3 |
|
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="1"
Months="6"
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
|
primary hypothyroidism is a relatively common endocrine disorder that affects people worldwide .hypothyroidism is posing a major health challenge in both developing as well as developed world. there is 2-5% prevelance of hypothyroidism in developed world .major portion of hypothyroidism remains undetected . incidence of hypothyroidism is more in females. (6:1) and is a leading cause of infertility in elderly patients.the incidence of hypothyroidism increases with age.modern allopathic medicine manages hypothyroidism primarily through harmone replacement therapy.does have certain limits .although levothyroxine remains standerd treatment ,it may cause adverse effects such as palpitations ,arrythmia,weight loss, angina,depression, and infertility.furthermore its use is restricted in patients with certain co morbidities like ischemic heart diasease espcially when treated concurrently with anticoagulants like heparin. modern medicine focuses on managing symptoms rather than adressing potential root causes like autoimmune dysfunction or lifestyle factors .from an ayurvedic perspective ,hypothyroidism is not identified as a single entity in classical texts .itstead it is interpreted through the lens of dosha imbalance and related conditions .based on ayurvedic principle,the clinical features of primary hypothyroidism suggest a dushti (vitiavtion)of kapha and vata doshas along with meda and rasa dhatus. in later stages ,other dhatus may become involved as well .to explore alternative management approaches ,the ayurvedic formulation kanchnar shunti ghanvati has been selected for evaluation due to its vata-kapha imbalancing and deepana (digestive stimulant)properties .it is speecifically indicated in galganda making it relevant for hypothyroid conditions. |