| CTRI Number |
CTRI/2018/08/015509 [Registered on: 28/08/2018] Trial Registered Prospectively |
| Last Modified On: |
26/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role Of Ayurveda Medication In the Treatment of Hypothyroidism |
|
Scientific Title of Study
|
Effect Of Whole System Approach Of Ayurveda Intervention On Primary Hypothyroidism A Randomized Control Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa OPD No 06 and IPD KLE Ayurveda Hospital and Research Center Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
Belgaum
KARNATAKA
Dr Vivek
India |
| Phone |
9812360008 |
| Fax |
|
| Email |
rajpur.vivekrana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa OPD No 06 and IPD KLE Ayurveda Hospital and Research Center Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
Belgaum
KARNATAKA
Dr Vivek
India |
| Phone |
9812360008 |
| Fax |
|
| Email |
rajpur.vivekrana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj Tubaki |
| Designation |
Professor HOD Department of Kayachikitsa |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa OPD No 06 and IPD KLE Ayurveda Hospital and Research Center Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 590003 |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vivek |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek |
KLE Ayurveda Hospital and Research Center |
Department of Kayachikitsa OPD No 06 and IPD KLE Ayurveda Hospital and Research Center Shahapur Belagavi Karnataka
Belgaum
KARNATAKA |
9812360008
rajpur.vivekrana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Individuals of either between the age group of 20 to 60 years
Patients on Anti hypothyroidism drugs
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP-A
Kanchnar guggulu |
Kanchnar guggulu 2 tab of 500 mg tid
ABOVE DRUG WILL BE ADMINISTERED FOR 60 DAYS |
| Intervention |
GROUP-B
Whole system research of Ayurveda Interventions |
KAPHAHARA
Yastimadhu churna 3-6gm, tid
Kaphaketu rasa 30-60mg (1/4ratti)
Mandura vataka (1-2tab)bd
Punarnava Mandura 250mg tid
Asan eladi taila
Punarnavasava 10-15 ml tid
Punarnavadi guggulu 2tab of 500mg tid
Asandi kwatha 15 ml tid
Cap Shilajatu 500mg bd
cap.Gomutra haritaki 500 mg tid
Agnitundi vati 125 mg bd
Trikatu churna 3-6 gm
Ashokarista 15ml tid
Raja pravartini vati 3-6 ratti (250 mg TID)
Punarnavadi guggulu2 tab of 500 mg tid
Varunadi kwatha 15 ml tid
Punarnavasava 10-15 ml tid
Punarnavadi guggulu2 tab of 500 mg tid
Varunadi kwatha 15 ml tid
Navaka guggulu 500 mg bd
cap Shilajatu 500 mg bd
Asandi kwatha 15 ml bd
Triphala churna 3-6 gm
Katuki churna 0.5-1gm
Haritaki churna 3-6 gm
Sarswata churna 3-6gm tid
Dashamoolarista 10-15 ml bd
Brahmi vati 500mg tid
Jyotismati taila –Pratimarsha nasya-2drops
VATAKAPHAHARA
Eladi vati 250mg tid
Maha tiktaka ghruta 10 ml bd
Dhatri loha 250-500mg
Asana eladi taila
Dhanwantara ghruta 10ml BD
Hingwasthak churna
Phala ghruta 10 ml bd
Punarnavadi guggulu 2 tab of 500 mg tid
Amrutadi guggulu 500 mg tid
Gokshuradi guggulu 500 mg tid
Guggulu tiktaka ghruta 10 ml bd
Sukumar ghruta 10mlbd
Gandharva hastyadi eranda taila 10ml bd
Ashwagandharisth10-15 ml bd
Sarswataaristh 10-15 ml bd
ALL THE ABOVE SAID DRUGS WILL BE ADMINISTERED BASED ON THE AWASTHA AND SIGNS AND SYMPTOMS EXHIBITED BY THE PATIENTS
ABOVE DRUGS WILL BE ADMINISTERED FOR 60 DAYS
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of either between the age group of 20 to 60 years
Patients on Anti hypothyroidism drugs
|
|
| ExclusionCriteria |
| Details |
Patients with complications of hypothyroidism
Patients with alcohol dependency or drug dependency.
Pregnant or lactating women
Patients suffering from major systemic illness and long term
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Whole System Research approach if proved effective will validate the Chikitsa sootra and chiktsa of Ayurveda
Whole System Research will have greater implication on Ayurveda practioners
|
0th, 15th, 30th, 45th, 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
01/10/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothyroidism
is the major endocrine disorder seen in general population.It is characterized
by the deficiency of thyroid hormones to abnormal levels. In its
clinically overt form, hypothyroidism is a relatively common condition,
with an approximate prevalence of 2% in adult women and 0.2% in adult men. Early detection and proper management is very important. Under treatment leads
to disease progression with gradual worsening of symptoms and further metabolic
derangements. Fortunately, in most patients older than 3 years, the signs and
symptoms of hypothyroidism are reversed with thyroid hormone treatment.
Management of Hypothyroidism with the modern drugs may bring the value of
TSH, T3, T4 and FT4 to normal range but the increased dosage and continuous
medication are cost expensive and make the patient into drug dependent till the
end of mortal life. So, a better, safer and long lasting therapy is needed in
present scenario. Thus, this study is an attempt made to treat Hypothyroidism
with whole system approach by Ayurveda management. |