FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/05/042402 [Registered on: 06/05/2022] Trial Registered Prospectively
Last Modified On: 04/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical pilot study to evaluate effect of Nano Kanchanara Twak extract Capsule (Ayurvedic Medicine) in Hypothyroidism patients 
Scientific Title of Study   Experimental and Pilot Clinical Evaluation of safety and efficacy of Nano Kanchanara (Bauhinia variegata Linn) Twak Extract in Hypothyroidism 
Trial Acronym  YCNKET 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yakshi Choudhary 
Designation  Pg Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Opd no 116 dept of kayachikitsa parul ayurved hospital parul university post limda tel waghodiya dist vadodara india

Vadodara
GUJARAT
391760
India 
Phone  7983254783  
Fax    
Email  yakshichoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh V Deshpande  
Designation  Professor  
Affiliation  Parul Institute Of Ayurved 
Address  Opd no 116 dept of kayachikitsa parul ayurved hospital parul university post limda tel waghodiya dist vadodara gujarat india

Vadodara
GUJARAT
391760
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yakshi Choudhary 
Designation  Pg Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Opd no 116 dept of kayachikitsa parul ayurved hospital parul university post limda tel waghodiya dist vadodara gujarat india

Vadodara
GUJARAT
391760
India 
Phone  7983254783  
Fax    
Email  yakshichoudhary@gmail.com  
 
Source of Monetary or Material Support  
Department of Kaychikitsa Parul Institute Of Ayurved Parul university  
 
Primary Sponsor  
Name  Dean Faculty Of Ayurved  
Address  Parul institute of ayurved parul university Ap limda tel waghodiya dist vadodara gujarat india 391760 
Type of Sponsor  Private medical college 
 
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 Yakshi Choudhary  Parul Institute Of Ayurved  Opd No 116 Dept of Kayachikitsa Parul ayurved hospital parul university Post limda Tel waghodiya Dist Vadodara India 391760 Vadodara GUJARAT 391760 India
Vadodara
GUJARAT 		 7983254783

yakshichoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of ayurved-Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Tab LevothyroxineAllopathic Medicine- Tab Levothyroxine
2Intervention ArmDrugClassical(1) Medicine Name: Nano Kanchnara Extract Capsule, Reference: Charak Samhita, Sutra Sthan, Annapanavidi adhyaya -27/104-105, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Nano Kanchnara Extract Capsule is a herbal formulation contains nano Kanchanara extract powder
3Intervention ArmDrugClassical(1) Medicine Name: Nano Kanchnara Extract Capsule , Reference: Charak Samhita, Sutra Sthan, Annapanavidi adhyaya -27/104-105 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Nano Kanchnara Extract Capsule is a herbal formulation contains nano Kanchanara extract powder.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients of either gender with age group 20-60 Years (both years inclusive)
2) Elevated level of serum TSH more than normal range (i.e. 0.4 -5.0 μIU/ml)
3) Patients having clinical features of hypothyroidism-
a. Puffiness of face and eyelids
b. Peripheral edema
c. Dry coarse skin
d. Breathlessness
e. Constipation
f. Weakness
g. Lethargy
h. Fatigue
i. Muscle ache
j. Menstrual abnormality
k. Hair loss 
 
ExclusionCriteria 
Details  1)Known case of any chronic and severe systemic disorder including IHD, CVA, uncontrolled Hypertension, uncontrolled diabetes, CRF, Active Malignancy Disease
2)Pregnant and lactating females
3)Known case of congenital hypothyroidism and secondary hypothyroidism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect on level of TSH value  The efficacy of treatment will be assessed on the level of TSH value at baseline and at the end of 90 days  
 
Secondary Outcome  
Outcome  TimePoints 
1) Effect on subjective parameter on the basis of Billewicz Diagnostic Index and a standard gradation scale.
2) BMI
3) Lipid Profile
4) Hemogram 		 The efficacy of treatment will be assessed on the basis of Billewicz Diagnostic Index and a standard gradation scale and BMI at baseline and at the end of 15 days till 90 days.
Lipid Profile, Hemogram will be assessed at baseline and at the end of 90 days 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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 2 
Date of First Enrollment (India)   12/05/2022 
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   Nil 
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 hormone for prolonged period or rarely, from resistance of the peripheral tissue to the effect of thyroid hormones. Primary hypothyroidism is a dysfunction in the thyroid gland and, it can be sub-clinical or overt. Due to easily stimuli like stress and anxiety, the global incidence of hypothyroidism is increasing.
Kanchanara reduce the swelling of neck, increased serum thyroid hormone concentration, decreased cholesterol and improve thyroid histology.
Kanchanara stem bark has been investigated and reported to have anti-tumor property. 
Kanchanara extract, as standardized extracts, provide unlimited opportunities for uncovering new drug because of the innumerable availability of chemical composition.
Prevalence rate of Hypothyroidism in developed countries is 4.6% . Where as in India it is 10.95%. Incidence rate of hypothyroidism is more in females (15.86%) than males (5.02%). 
Lacunas in current management. HRT is the single available treatment & Long-term metabolic complications of HRT. Increased dosage and continuous medication make the patient drug dependent till the end of the life. So therefore need to find new drug which will prevents further lacunas hence extraction of  Kanchanar Twak will help to concentrate the chemical constituent in a soluble form and by using Nanotechnology we will able to level up herbs bioavailability, effectiveness and also able to reintroduce other component that were discarded due to poor characteristics.

 
Close