| CTRI Number |
CTRI/2024/01/062170 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of the effect of Virechan and Shilajit in comparision to Thyroxine Sodium in the management of Hypothyroidism |
|
Scientific Title of Study
|
Evaluation of the effect of Virechan and Shilajit in comparision to Thyroxine Sodium in the management of 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 Sonika Solanki |
| Designation |
P G Scholar |
| Affiliation |
Pandit Khushilal Sharma Government Ayurveda college and Institute Bhopal |
| Address |
PG Department of Panchakrma, Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Kolar bypass Bhopal
PG Department of Panchakrma,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Kolar bypass Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9826796709 |
| Fax |
|
| Email |
solankisonika1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Chaturvedi |
| Designation |
Reader |
| Affiliation |
Pandit Khushilal Sharma Government Ayurveda college and Institute Bhopal |
| Address |
PG Department of Panchakrma, Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Kolar bypass Bhopal
PG Department of Panchakrma, Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Kolar bypass Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7999013557 |
| Fax |
|
| Email |
preetichaturvedi227@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonika Solanki |
| Designation |
PG Scholar |
| Affiliation |
Pandit Khushilal Sharma Government Ayurveda college and Institute Bhopal |
| Address |
PG Department of Panchakrma, Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Kolar bypass Bhopal
PG Department of Panchakrma, Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Kolar bypass Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9826796709 |
| Fax |
|
| Email |
solankisonika1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Panchakarma, Pt. Khushilal Sharma Govt. Autonomous Ayurveda College and Institute Bhopal |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt (Autonomous) Ayurveda College and Institute Bhopal (MP) |
| Address |
Pt. Khushilal shrma Govt. Autonomous Ayurveda College and Institute, Science Hills Nehru Nagar Bhopal |
| Type of Sponsor |
Government funding agency |
|
|
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 Sonika Solanki |
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) |
PG Department of Panchakrma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
Bhopal
MADHYA PRADESH |
9826796709
solankisonika1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Pt Khushilal Sharma Govt Autonomous Ayurveda College and Institute Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: KAPAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Shahatra Yog 15, Procedure details: virechana Planed with Trivritadi kashayam and erand tail)
(1) Medicine Name: Shilajit, Reference: Charak Chikitsa 28, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Thyroxin Sodium | |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed case of Hypothyroidism.
Patients age between 25 years to 45 years.
Patients those fit for Virechan Karma.
|
|
| ExclusionCriteria |
| Details |
All complicated cases of Hypothyroidism, myxedema, severe mental illness, thyroid cancer etc. and other disease associated with endocrine imbalance.
Patients having chronic systemic illness.
Congenital hypothyroidism
Pregnant women and Lactating Mother.
Patients having undergone thyroid surgery.
Patients those unfit for Virechan Karma.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we would be able to demonstrate the effects of virechan karma and shudhh shilajit in the management of hypothyroidism. It is further expected that this study would be able to provide comparative efficacy between the trialed treatment to that of standard controle ie. Thyroxine sodium. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thyroxin Sodium is more effective than Virechana Karma And Shuddha Shilajit |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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
|
It is expected that at the end of the study we would be
able to demonstrate the effects of virechan karma and shudhh shilajit in the
management of hypothyroidism. It is further expected that this study would be
able to provide comparative efficacy between the trialed treatment to that of
standard controle ie. Thyroxine sodium. |