| CTRI Number |
CTRI/2024/05/066731 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check the efficacy of Vidanga churna with kulattha yusha and yoga in three different groups |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Kulattha Yusha As Pathya Selected Yoga Techniques Over Vidanga Choorna As Shamanoushadhi In The Management Of Hypothyroidism. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic Medical College and Hospital , Mysuru |
| Address |
Department of Swasthavritta, Government Ayurveda Medical College and Hospital, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla
Mysore
KARNATAKA
570001
India |
| Phone |
7411988706 |
| Fax |
|
| Email |
aishu1997c@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheendra G Nawale |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic Medical College and Hospital , Mysuru |
| Address |
Department of Swasthavritta, Government Ayurveda Medical College and Hospital, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla
Mysore
KARNATAKA
570001
India |
| Phone |
9341061821 |
| Fax |
|
| Email |
sudhi130207t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic Medical College and Hospital , Mysuru |
| Address |
Department of Swasthavritta, Government Ayurveda Medical College and Hospital, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla
Mysore
KARNATAKA
570001
India |
| Phone |
7411988706 |
| Fax |
|
| Email |
aishu1997c@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya |
| Address |
Government Ayurveda Medical College and Hospital, Mysuru |
| 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 |
Government Ayurveda Medical College and Hospital |
Room-12,Department of Swastha
Mysore
KARNATAKA |
7411988706
aishu1997c@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda Medical College & Hospital Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: AMADOSHAH, (2) ICD-10 Condition:E078||Other specified disorders of thyroid. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidanga, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Break fast - Kulattha yusha 100ml for 60 days
Lunch - Normal diet
Dinner - Normal Diet , Apathya:Avoid curd , Idali, dosa
Avoid Anti goitrogenic substances like Cabbage, Cauliflower, Soyabean, Broccoli etc. | | 3 | Comparator Arm (Non Ayurveda) | | - | Yoga | Hypothyroidism yoga protocol is advised
for 1 week training will be given to precipitants,
yoga intervention for 60 days once in a day. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subject belonging to Age group 20 to 50 years irrespective of gender are included
Subject with the TSH value more than 5.5mIU/L to less than 25mIU/L not be associated with the routed value of T3 and T4 |
|
| ExclusionCriteria |
| Details |
Subject with congenital hypothyroidism chronic history of hypothyroidism less more than 5yrs and secondary hypothyroidism
Subject having any of the diagnosed systemic illness which interrupt the present intervention
Subject with toxic goiter pregnant and lactating women are excluded
Subject who has undergoes any thyroid surgery |
|
|
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 |
| Efficacy of Kulattha yusha vidanga choorna yoga in reducing the TSH value by comparing the zulewski clinical score for hypothyroidism |
61th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Kulattha yusha Vidanga choorna Yoga in relieving other associated symptoms of Hypothyroidism like weight gain Stiffness of joints Hair loss Diminished sweating Dry skin Constipation |
61th day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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
|
Thyroid disease is one of the most prevalent endocrine disorders worldwide Hypothyroidism
is a hypo-metabolic clinical state resulting from inadequate production of thyroid hormone This condition is associated with symptoms like poor appetite weakness or tiredness feeling
of cold poor memory constipation and weight gain Prevalence of hypothyroidism in India is
around 11% and Females suffer more than male with ratio 6:1 prevalence of clinical
Hypothyroidism is about 4%.
Thyroid hormone regulates all metabolic activities in the body it can be compared to
Dhatvagni. While analysing the signs and symptoms of Hypothyroidism in Ayurvedic view Agnimandya due to Kapha Vata Vriddhi and Pittakshaya is seen This is due to unhealthy food
habits non-nutritious food sedentary life styles & stress
In this present study hypothyroidism is selected by observing its incidence and it is an attempt
to cure the disease from its root cause As the incidence of hypothyroidism is due to improper
dietary habits and iodine deficiency changes in diet and lifestyle plays a major role in control
of thyroid hormone level In Ayurveda much importance is given to Pathyahara sevana (Diet)
and Yoga Proper pathyahara sevana holds an important role in diseased condition than
medicine by regulating the metabolism function (Agni) of body and balancing the tridosha
Kulatta yusha is having Kaphavatahara, Medhoghna Agni Dipaka properties Vidanga is Agni Dipana and Pachana Vata Anulomana Yogasana and Pranayama helps in
total physical and mental wellbeing Improves metabolic process and helps to reduce body
weight and stress Pranayama is a breathing process that is directly connected with brain and
central nervous system it also has a strong connection with the functioning of hypothalamus Thus this study is designed to evaluate the effect of Kulattha yusha as a Pathya selected yoga
techniques along with Vidanga churna as a shamanaoushadi individually and also to compare
their efficacy with one another in Hypothyroidism |