| CTRI Number |
CTRI/2025/02/080271 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial of
Vyoshadi Tablet in Hypothyroidism |
|
Scientific Title of Study
|
An Open Labelled Randomized Controlled Trial to evaluate the Efficacy of
Vyoshadi Guggul along with Thyroxine in 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 |
Yogesh Tukaram Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal Parashram Salunke |
| Designation |
P.G. student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
08788585617 |
| Fax |
|
| Email |
kunalsalunke209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal Parashram Salunke |
| Designation |
P.G. student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
08788585617 |
| Fax |
|
| Email |
kunalsalunke209@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved College Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Kunal Parashram Salunke |
| Address |
OPD NO. 2
First Floor
Kayachikitsa Department
Malwadi Hadapsar Pune |
| 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 Kunal Parshram Salunke |
Saneguruji Arogya Kendra |
MAMS Sumatibhai Shah Ayurved College Hadapsar Pune 411028
Pune
MAHARASHTRA |
09423218193
kunalsalunke209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | THYROXINE | 1.6 mcg/Kg once early in the morning | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: VYOSHADI GUGULU, Reference: ASHTANG HRUDAY, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: KOSHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the ages of 19 years to 50 years with irrespective sex, cast, religions.
2. Patient currently on Tab. Thyroxine 25 mcg to 100 mcg
3. Patient who has stopped treatment since 3 months or more and has any one of T3, T4 and TSH levels uncontrolled
4. Chronicity of hypothyroidism below 5 years. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of the Vyoshadi Guggul as an add-on effect in reduction of the symptoms of Hypothyroidism |
2 weeks 4 weeks 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
20/02/2025 |
| 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="1"
Months="5"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
we are not in a position to treat Thyroid Disorders only with Ayurvedic drugs. Therefore, this study has been planned to provide better, safer and faster relief to the patients suffering from Hypothyroidism Therefore, now the time has come for evaluation of add-on therapy in such type of diseases. Add-on means, that which assists especially a drug added to a prescription to hasten or increase the action of the drug. Therefore, for the management of Hypothyroidism, an adjuvant therapy besides increasing the action of Modern drugs directly on the hormones should be initiated which can reduce time and also make the treatment more cost- effective. Ayurveda with great hope and definitely Ayurveda has a golden treasure of natural ways of healing and a vast pharmacopoeia of Rasayana drugs that can provide such an effective adjuvant therapy. Keeping wellbeing of humanity as chief concern, if the best of two pathy are combined, without making much choose about the purity of science, an effective and successful. So keeping these facts in mind this study has been planned to provide better, safer and faster relief to patients suffering from Hypothyroidism and for this purpose this Vyoshadi Guggulu has been used. |