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
|
|
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
|
|
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
|
|
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 people1. Management
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. |