| CTRI Number |
CTRI/2022/07/043813 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect Of Vipritkarni Mudra And Ujjayi Pranayama In Hypothyroidism |
|
Scientific Title of Study
|
Anatomical study of vishuddh chakra with therapeutic effect of vipritkarni mudra and ujjayi pranayama in hypothyroidism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaifali sharma |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan |
| Address |
Department of Rachana sharir
Madan Mohan Malviya Government Ayurved College, Ambamata Scheme, Rada Ji Circle, Udaipur, Rajasthan
Madan Mohan Malviya Government Ayurved College, Ambamata Scheme, Rada Ji Circle, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9462771027 |
| Fax |
|
| Email |
Sharmashaifali44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kumar Sharma |
| Designation |
Assistant Professor & Guide |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan |
| Address |
PG Department of Rachana Sharir
Madan Mohan Malviya Government Ayurved college,Ambamata scheme,Rada ji circle,Udaipur
Madan Mohan Malviya Government Ayurved College, Ambamata Scheme, Rada Ji Circle, Udaipur, Rajasthan
Udaipur
RAJASTHAN
303001
India |
| Phone |
6350531994 |
| Fax |
|
| Email |
drdineshanatomy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Kumar Sharma |
| Designation |
Assistant Professor & Guide |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan |
| Address |
PG Department of Rachana Sharir
Madan Mohan Malviya Government Ayurved college,Ambamata scheme,Rada ji circle,Udaipur
Madan Mohan Malviya Government Ayurved College, Ambamata Scheme, Rada Ji Circle, Udaipur, Rajasthan
Pali
RAJASTHAN
303001
India |
| Phone |
6350531994 |
| Fax |
|
| Email |
drdineshanatomy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College,Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College, Ambamata Scheme, Rada Ji Circle, Udaipur, Rajasthan |
| Type of Sponsor |
Government medical 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 Shaifali Sharma |
Madan Mohan Malviya Government Ayurved College |
OPD No:2
PG Department of Rachana sharir
Madan Mohan Malviya Government Ayurved college
Udaipur
RAJASTHAN |
9462771027
Sharmashaifali44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Madan Mohan Malviya Government Ayurved college,udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA), (2) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Vipritkarni Mudra
twice a day for 3 months, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Ujjayi pranayama
Twice a day for 3 months , Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Vipritkarni Mudra and Ujjayi pranayama
Twice a day for 3 months., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients suffering from signs and symptoms of hypothyroidism. |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from cardiac diseases.
2)Patients having extremely high or low blood pressure.
3)Pregnant women and women under menstruation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs and symptoms of hypothyroidism
2)Improvements in T3,T4 and TSH values |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs and symptoms of hypothyroidism
2)Improvements in T3,T4 and TSH values. |
1 month,2 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/07/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to evaluate the therapeutic effect of Vipritkarni Mudra and Ujjayi pranayama in hypothyroidism.This is a multiple arm study in which first group will be adviced with Vipritkarni Mudra,second group with Ujjayi pranayama and the third group with both Vipritkarni Mudra and Ujjayi pranayama. |