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CTRI Number  CTRI/2021/01/030426 [Registered on: 13/01/2021] Trial Registered Prospectively
Last Modified On: 09/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the effect of Jalandhar Bandha on Kaphaja Galganda with special reference to hypothyroidism 
Scientific Title of Study   A Randomized Controlled Clinical Study Of Add On Effect Of Jalandhara Bandha With Hormone Replacement Therapy On Kaphaj Galganda With Special Reference To Hypothyroidism”.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jivan Prabhakar Hanwate 
Designation  PG SCHOLAR 
Affiliation  Government ayurved college vazirabad Nanded 
Address  Government ayurved college vazirabad, Nanded Maharashtra 431601
At post Babhulgaon Tal- sengaon Dist- Hingoli
Nanded
MAHARASHTRA
431601
India 
Phone  09373769622  
Fax    
Email  drjivanhanwate@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jivan Prabhakar Hanwate 
Designation  PG SCHOLAR 
Affiliation  Government ayurved college vazirabad Nanded 
Address  Government ayurved college vazirabad, Nanded Maharashtra 431601
At post Babhulgaon Tal- sengaon Dist- Hingoli
Nanded
MAHARASHTRA
431601
India 
Phone  09373769622  
Fax    
Email  drjivanhanwate@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shital Onkarsingh Chavan 
Designation  Assistant professor department of Swasthavritta,GAC NANDED 
Affiliation  Government ayurved college vazirabad Nanded 
Address  Government ayurved college vazirabad, Nanded Maharashtra 431601
Bhagyanagar,Nanded Tal- Nanded Dist- Nanded
Nanded
MAHARASHTRA
431601
India 
Phone  09373769622  
Fax    
Email  drshitalchavan@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College, vazirabad,Nanded 
 
Primary Sponsor  
Name  Jivan Prabhakar Hanwate 
Address  Government ayurved college vazirabad Nanded 
Type of Sponsor  Other [Own funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jivan Prabhakar Hanwate  Government Ayurved College and Hospital  Department of swasthvritta and Yoga, OPD no- 19 Vajirabad Nanded
Nanded
MAHARASHTRA 		 09373769622

drjivanhanwate@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: KAPHAJ GALGAND,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hormone replacement therapy for Hypothyroidism  Hormone replacement therapy for Hypothyroidism will be given to both the groups.Tablet Thyroxine of appropriate dose according to the TFT values will be given per orally for period of study that is 2 months ( 8 weeks). 
Intervention  Jalandhar Bandha  Jalandhara Bandha daily at 6:30 am for 10 min and subject will be asked to continue his Hormone replacement therapy he is taking for next 60 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Already diagnosed subjects taking Hormone replacement therapy like thyroxin since last six months.
2. New subjects having signs and symptoms of Hypothyroidism with elevated TSH.
3. Subjects of age between 20-60 years of either gender.
3. Subjects with 1. TSH ≥ 5.50 μIU/ml (Electro chemiluminescence) and
2. T4 ≤ 4.6 μg/dl (Electro chemiluminescence)
3. T3 ≤ 60 ng/dl (Electro chemiluminescence) 
 
ExclusionCriteria 
Details  Already diagnosed subjects taking Hormone replacement therapy like thyroxin more than last six month.
CA Thyroid, Thyroidectomy and having Thyroid complications.
Subjects suffering from Cardiac Disease, Hypertension.
Hypothyroidism in Pregnancy.
Subjects who are already doing regular or irregular Jalandhara Bandha since 1 year.
Subjects with cervical, lumbar spondylosis or injury to Neck.
Subjects who are not willing for the study trial.
Subjects who had undergone abdominal surgeries minimum three months period. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in raised TSH level  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in weight, BMI, constipation,  60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/01/2021 
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="2"
Months="0"
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   Purpose of trial is to find out weather ancient Yoga techniques (Jalndhara bandha) is usefull in thyroid disorders ( Hypothyroidism)

The trial will help find out some new ways which will be usefull in managing non comunicable   diseases like hypothyroidism, help reducing the dose of Hormone replacement therapy, help reduce the sign and symptoms of Hypothyroidism with a low cost modality.
 
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