| CTRI Number |
CTRI/2025/02/081276 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| 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 in Hypothyroidism. |
|
Scientific Title of Study
|
Randomised Controlled Trial To Study The Efficacy of Vasadi Ghanvati In Primary Hypothyroidism with Reference To Kaphaj Pandu. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Dattatray Satre |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala ayurved mahavidyalay, sangamner |
| Address |
OPD number 1, Kayachikitsa department, Siddhakala Ayurved mahavidyalaya, Pimparne road , sangamnner Ahmadnagar ,Maharashtra , 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7083902742 |
| Fax |
|
| Email |
shraddhasatre.4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Gorakh Mane |
| Designation |
Professor in kayachikitsa |
| Affiliation |
Siddhakala ayurved mahavidyalay, sangamner |
| Address |
Kayachikitsa department Siddhakala Ayurved mahavidylay, Pimparne road, sangamner.
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9420014073 |
| Fax |
|
| Email |
drsgmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Gorakh Mane |
| Designation |
Professor in kayachikitsa |
| Affiliation |
Siddhakala ayurved mahavidyalay, sangamner |
| Address |
Kayachikitsa department Siddhakala Ayurved mahavidylay, Pimparne road, sangamner.
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9420014073 |
| Fax |
|
| Email |
drsgmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya, Pimparne road , Sangamner khurd, Sangamner , Ahilyanagar , Maharashtra , India.
Pincode- 422605. |
|
|
Primary Sponsor
|
| Name |
Shraddha Dattatray Satre |
| Address |
Siddhakala Ayurved Mahavidyalaya, Pimparne road , Sangamner khurd, Sangamner , Ahilyanagar , Maharashtra , India.
Pincode- 422605 |
| 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 Shraddha Dattatray Satre |
Siddhakala ayurved mahavidyalay, sangamner |
Kayachikitsa OPD of Siddhakala ayurved mahavidyalay, sangamner, Ahmadnagar,
Ahmadnagar
MAHARASHTRA |
7083902742
shraddhasatre.4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala ayurved mahavidyalay, sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Thyroxine | Tab Thyroxine 25 mcg OD , Orally , in morning empty stomach, before breakfast | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasadi Ghanavati, Reference: Asthang-Hridya Samhita Chikitsasthan, Chapter 16, Shloka no. 13 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: - Madhu (Honey)), Additional Information: Aushadh Sevan Kala-Vyanodana Kala |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases of Hypothyroidism diagnosed according to classical features
, Patients having TSH level between 4 to 20 mIU/L, Patients having T3 (0.8-2.0 ng/mL) and T4 (5.0-12.0 µg/dL), Those patients of newly diagnosed with Hypothyroidism |
|
| ExclusionCriteria |
| Details |
Patients having TSH level greater than 20 mIU/L, Recent thyroid surgery within 12 months, patients on prolonged medications more than 6 weeks with corticosteroid, thyroid replacement therapy, iron supplements, pregnant females and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of oral administration of 250 mg Vasadi. Ghan Vati twice a day with madhu for 45 days in management of primary hypothyroidism with reference to Kaphaj pandu |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the etiopathogenesis of Kaphaj pandu in detailed according to Ayurveda and hypothyroidism in detail according to modern aspect
To study the properties and efficacy of Vasadi Ghan Vati with madhu.
To evaluate the effect of Vasadi Ghan Vati with madhu in lowering Sr. TSH.
To evaluate the effect of vasadi Ghan Vati with madhu on Sr T3 and T4. |
15 days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="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
|
This study is a randomised open labelled controlled clinical trial comparing the safety and efficacy of Vasari Ghan Vati 250 mg and Controlled Tablet Thyroxine 25 mcg for 45 days in 80 patients with primary hypothyroidism and effect on TSH, T3, T4 levels. |