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CTRI Number  CTRI/2019/08/020830 [Registered on: 21/08/2019] Trial Registered Prospectively
Last Modified On: 19/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Hypothroidism 
Scientific Title of Study   A Comparative Clinical Study to Evaluate the Efficacy of Katutumbi taila and Himsradi taila as Marsha Nasya 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  AISHWARYA LAKSHMI BR 
Designation  Panchakarma PG Scholar 
Affiliation  GOVERNMENT AYURVEDA MEDICAL COLLEGE, BENGALURU 
Address  Government Ayurveda Medical college Dhanvantari Road Bengaluru Karnataka 560010
13/1, 7th B Cross, Eshwara Layout, LBS Nagar, Indiranagar, Bengaluru 560038
Bangalore
KARNATAKA
560010
India 
Phone  09035690783  
Fax    
Email  chaitrabairy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santosh L Yadahalli 
Designation  Associate Professor 
Affiliation  Rajiv Gandhi University of Health Sciences, Bangalore 
Address  Government Ayurveda Medical college Dhanvantari Road Bengaluru Karnataka 560010

Bangalore
KARNATAKA
560010
India 
Phone  09902322355  
Fax    
Email  ayursantosh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  AISHWARYA LAKSHMI BR 
Designation  Panchakarma PG Scholar 
Affiliation  GOVERNMENT AYURVEDA MEDICAL COLLEGE, BENGALURU 
Address  Government Ayurveda Medical college Dhanvantari Road Bengaluru Karnataka 560010
13/1, 7th B Cross, Eshwara Layout, LBS Nagar, Indiranagar, Bengaluru 560038
Bangalore
KARNATAKA
560010
India 
Phone  09035690783  
Fax    
Email  chaitrabairy@gmail.com  
 
Source of Monetary or Material Support  
Dr Aishwarya Lakshmi B.R 
 
Primary Sponsor  
Name  Dr Aishwarya Lakshmi BR 
Address  GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BANGALORE-560009 
Type of Sponsor  Other [Self] 
 
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 
Dr Aishwarya Lakshmi BR  Sri Jayachamarajendra Institute of Indian Medicine and Hospital  Sri Jayachamarajendra Institute of Indian Medicine and Hospital,Government Ayurveda Medical college Campus, Dhanvantari Road, Bengaluru, Karnataka 560010
Bangalore
KARNATAKA 
09035690783

chaitrabairy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E038||Other specified hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Himsradi Taila  3ml of Himsradi Taila is administered to each nostril for 7 Alternate days 
Comparator Agent  2. Katutumbi Taila  3ml of Katutumbi Taila is administered to each nostril for 7 Alternate days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects with clinical signs and symptoms of Hypothyroidism and Serum Thyroid Levels suggesting Hypothyroidism
2. Subjects fit for Marsha Nasya 
 
ExclusionCriteria 
Details  1. Subjects diagnosed with cardiac disorders, Hashimoto thyroiditis, Thyrotoxicosis, congenital anamolies and carcinomas of the thyroid gland, Myxedema and its complications
2. Pregnant and Lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Serum TSH
2.Easy Fatigue
3.Hairfall 
45 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Dry Skin
2.Somnolence 
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   N/A 
Date of First Enrollment (India)   30/08/2019 
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="8"
Days="30" 
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)?  

Brief Summary  

Nasya Karma, one among Panchakrama is a process by which medicated oil is administered through the nostrils to alleviate diseases of jatrurdwa.

The sedentary lifestyle and stress filled modern era has led to alterations in the activities of neuro-endocrine systems causing newer health challenges like hypothyroidism. Hypothyroidism, occurs when the thyroid gland does not produce enough thyroid hormones. It is continued to be posing a major health challenge in both developing and developed world. There is 4.5% prevalence of Hypothyroidism in developed world. The prevalence of subclinical hypothyroidism in developed world is 4-15%. The prevalence of hypothyroidism in urban India is 10.95%. Major portion of Hypothyroidism remain undetected. Incidence of Hypothyroidism is more in females (7:1) and elderly people1Management of Hypothyroidism with the modern drugs may bring the value of TSH and T4 to normal range, but increased dosage and continuous medication make the patient drug dependent till the end of mortal life. So a better and safer therapy is needed for the patient society through the heritage of Ayurveda. Hence an effort is made to treat hypothyroidism in a safer and effective way.

The thyroid disorders can be studied under Galaganda. Involvement of Kapha is invariable associated with Kupita vata and dusta Medas2a. The stana of thyroid gland being jatrurdwa and being a kapha stana, Marsha Nasya is selected for its shodana action.Previously a work on Katutumbi taila Nasya with katu taila3a base was done, which had very good results. However Subjects had irritation in nose due to its atiteekshna guna, hence in order to reduce its teekshnata, Katutumbi taila with tila taila4a as the base is used in present study. This is compared to Himsradi taila4b Nasya which also has usna and teekshna guna, thus the desired shodana effect is achieved.

 
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