| CTRI Number |
CTRI/2024/02/062330 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"The Management Of Hypothyroidism Through Ayurvedic Treament Regimen" |
|
Scientific Title of Study
|
"Exploring The Efficacy Of Varunadi Ghan Vati And Basti Karma 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 Shraddha Saraf |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma
Government (Autonomous) Ayurveda College and Institute
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8109468953 |
| Fax |
|
| Email |
drshraddha8109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Nagpal |
| Designation |
Reader |
| Affiliation |
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma
Government (Autonomous) Ayurveda College and Institute
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8109468953 |
| Fax |
|
| Email |
swalng05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Saraf |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma
Government (Autonomous) Ayurveda College and Institute
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8109468953 |
| Fax |
|
| Email |
drshraddha8109@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal MP |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt. Khushilal Sharma Government
(Autonomous) Ayurveda College and Institute, Bhopal (MP) |
| 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 Shraddha Saraf |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute |
Post Graduation Department of Kayachikitsa
Science Hills Nehru Nagar kolar bypass road,BHOPAL 462003
Bhopal
MADHYA PRADESH |
8109468953
drshraddha8109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Pt. Khushilal Sharma Government (Autonomous) Ayurvedic College Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: DHATVAGNIMANDYA EVUM KAPHAAVRUT VATA, (2) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: KAPAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 2 | Intervention Arm | Drug | Classical | | | | 3 | Comparator Arm (Non Ayurveda) | | - | Thyroxine Sodium | Thyroxine Sodium As Directed by modern physician |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed case of hypothyroidism
2. Patients age should be above 20 years and below 60 years
3. Based on thyroid profile elevated level of serum TSH level or low
level of serum T3 & T4. However the cases of which T3 & T4 levels
are within normal range and TSH level is high will also included.
4. Patients those have given written consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. All complecated cases of hypothyroidism goiter, myxoedema,
severe mental illness, thyroid cancer etc and other associate with
other endocrine disorders.
2. Patients having chronic systemic illness.
3. Congenital hypothyroidism.
4. Pregnant women and lactating mother.
5. Patients having undergone thyroid surgery |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected at the end of the study we should be able to
demonstrate the efficacy of Ayurvedic treatment protocol in the management of hypothyroidism. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected at the end of the study we should be able to
demonstrate the effects of varunadi ghan vati & basti karma in the clinical signs & symptoms of hypothyroidism. |
15 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/ Phase 2 |
|
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="0"
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 at the end of the study we would be able to demonstrate the efficacy of ayurvedic treatment protocol in the management of hypothyroidism.It is further expected that this study would be able to provide efficacy of ayurvedic treatment regimen in comparative to modern management. |