| CTRI Number |
CTRI/2024/07/070125 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management Of Hypothyroidism |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Combined Effect Of AVP Churna
(Indigenous Formulation) With Kanchanara-Triphala Kwath
And Brahmi Taila Pratimarsha Nasya In Hypothyroidism.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghna S Dhapse |
| Designation |
second year PG scholar |
| Affiliation |
government ayurveda medical college ,mysuru |
| Address |
second year PG scholar department of kayachikitsa government ayurveda medical college ,mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
9168469713 |
| Fax |
|
| Email |
meghnadhapse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mythrey R C |
| Designation |
Professor and Head of Department |
| Affiliation |
government ayurveda medical college ,mysuru |
| Address |
Professor and Head of Department of Kayachikitsa Government Ayurveda Medical College Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
8618570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meghna S Dhapse |
| Designation |
second year PG scholar |
| Affiliation |
government ayurveda medical college ,mysuru |
| Address |
second year PG scholar department of kayachikitsa government ayurveda medical college ,mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
9168469713 |
| Fax |
|
| Email |
meghnadhapse@gmail.com |
|
|
Source of Monetary or Material Support
|
| government ayurveda medical college ,mysuru 570001
government Hi-tech panchakarma hospital,570020 |
|
|
Primary Sponsor
|
| Name |
Dr Meghna Dhapse |
| 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 Meghna Dhapse |
Government Ayurvedic Medical College and Hospital |
Room Number 10 kayachikitsa OPD Government Ayurvedic Medical College and Hospital Mysore karnataka
Mysore
KARNATAKA |
9168469713
meghnadhapse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurvedic Medical College and Hospital GAMC Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AVP Choorna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: kanchanara triphala kwatha), Additional Information: - | | 2 | Intervention Arm | Procedure | - | pratimarsha nasya | (Procedure Reference: ashtanga hrudaya sutrasthana, Procedure details: The person should sit or lie down in a comfortable posture. After that the person has to undergo gentle massage over the forehead & face followed by mild Swedana (Sudation). Slightly warm 2 drops of brahmi taila should be Instilled in the prescribed dose in each nostril. The person is allowed to spit if he / she feel discomfort due to oil in the throat.)
)
(1) Medicine Name: Brahmi taila, Reference: ayurveda sara sangraha- taila prakarana, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with clinical and sub clinical hypothyroidism diagnosed through the thyroid profile will be included for the study
subjects with TSH values more than 4.5mIU/L to less than 25mIU/L |
|
| ExclusionCriteria |
| Details |
Subjects with Congenital Hypothyroidism and secondary Hypothyroidism will be excluded
Subjects who have undergone thyroid surgery will be excluded
Diagnosed case neoplastic and toxi goiter will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluating combined effect of AVP churna with kanchanara triphala kwath as anupana and brahmi taila pratimarsha nasya in management of hypothyroidism |
45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variations in Thyroid Profile Values |
On 46th day |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| 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="0"
Months="6"
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
|
Hypothyroidism is a hypo-metabolic clinical state resulting from inadequate production of thyroid hormones for prolonged period. Thyroid problems are the most common endocrine disorders presently seen worldwide and hypothyroidism is one of the most common functional disorders of thyroid gland. Prevalence of hypothyroidism is increasing every year. The present prevalence rate is 10.95%1. The global burden of hypothyroidism is significant. As there is an increasing incidence of hypothyroidism day by day and so there is increasing demand to find an effective alternative Ayurvedic treatment for this condition. Thyroid gland is situated in supraclavicular region, so it belongs to urdhwa -jatrugata bhaga as per Ayurveda. Here the sthanika doshas are kapha and vata dosha so there is an involvement of both of these doshas in the pathology of hypothyroidism showing symptoms like increase in body weight,poor appetite, fatigue, hairfall, irregular menses etc. Dry skin, tiredness, constipation, poor memory etc are some of the other symptoms associated with hypothyroidism. Aetiopathogenesis of hypothyroidism relates with jatharagni dushti resulting in dhatwagnimandya. Hence the intervention adopted in this study will be pratimarsha nasya2,3 as nasya is the main treatement for urdhwa jatrugata doshas4 . Brahmi taila 5 is selected for the pratimarsha nasya karma and an indigenous formulation AVP Churna containing amrita satwa- 2parts, vacha-1part and punarnava-4parts with kanchanara triphala kwatha as anupana will be administered as shamana aushadhi. All the drugs used in the above combination have kapha-vatahara, deepana, pachana, lekhana and medhya properties which may help in treating hypothyroidism.
|