| CTRI Number |
CTRI/2024/12/078496 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the result of Varanadi kashayam and Kanchanara guggulu in patients having Primary hypothyroidism(A condition where thyroid gland does not produce enough thyroid hormones - increased TSH and decreased T3, T4 values) |
|
Scientific Title of Study
|
Effect of Varanadi kashayam and Kanchanara guggulu in 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 |
Fenila Joseph |
| Designation |
2nd year PG Scholar |
| Affiliation |
Government ayurveda college Thiruvanathapuram |
| Address |
Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram
Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram
PIN 695001
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8301884186 |
| Fax |
|
| Email |
fenilajoseph97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravith N K |
| Designation |
Associate Professor |
| Affiliation |
Government Ayuveda college Thiruvananthapuram |
| Address |
Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravith N K |
| Designation |
Associate Professor |
| Affiliation |
Government Ayuveda college Thiruvananthapuram |
| Address |
Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college Thiruvananthapuram Pin 695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda college |
| Address |
Government Ayurveda college Thiruvananthapuram Kerala India PIN 695001 |
| Type of Sponsor |
Other [Government Ayurveda college ] |
|
|
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 Fenila Joseph |
Government Ayurveda college Thiruvananthapuram |
OP No 2 Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram Kerala PIN 695001
Thiruvananthapuram
KERALA |
8301884186
fenilajoseph97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Government ayurveda college Thiruvananthapuram Kerala India PIN 695001 |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varanadi kashayam, Reference: Ashtangahridayam sutrasthanam 15th chapter shloka 21-22, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchanara guggulu, Reference: Sarangadhara samhitha madhyamakhanda chapter 7 shloka 95-100, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants having Primary hypothyroidism, having serum TSH between 5-20mlU/L, irrespective of all gender between 18-60 years |
|
| ExclusionCriteria |
| Details |
Those who have undergone any type of thyroid surgery or tumor, who are under medication of hypothyroidism with any system of medicine, diagnosed case of acid peptic disorders, case of uncontrolled diabetes mellitus, hypertension, pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the TFT values |
Assessment will be done on 0th and 61st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Zulewskis clinical score |
Assessment will be done on 0th and 61st day |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
15/01/2025 |
| 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 Yet Recruiting |
| 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
|
The above study deals with assessing the effect of Varanadi kashayam and Kanchanara guggulu in Primary hypothyroidism. Evaluation is made on the changes in TFT values and Zulewskis clinical score. Assessment will be done on 0th and 61th day. |