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CTRI Number  CTRI/2022/11/047606 [Registered on: 24/11/2022] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ayurvedic treatment of hypothyroidism with help of Nano kanchanar  
Scientific Title of Study   Randomised double blind,placebo controlled evaluation of NANO KANCHANAR (Bauhinia variegata Linn)HYDRO ALCOHOLIC EXTRACT 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  Dr Hetvi D Dabhi 
Designation  PG Scholar 
Affiliation  Parul Institute Of Ayurveda 
Address  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital,Limda,Waghodia road Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9016988782  
Fax    
Email  dr.hetvidabhi03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailesh V Deshpande 
Designation  professor 
Affiliation  parul institute of ayurveda 
Address  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital,Limda,Waghodia road Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaishali S Deshpande 
Designation  Professor 
Affiliation  No 08 Kayachikitsa OPD Khemdas Ayurveda Hospital,Parul University,Ishwarpura,Waghodia ,Vadodara 
Address  OPD no 08 Kayachikitsa OPD Khemdas Ayurveda Hospital,Parul University,Ishwarpura,Waghodia ,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Source of Monetary or Material Support  
OPD No 116 Department of Kayachikitsa Parul ayurved hospital,parul university campus AP Limda Tal Waghodia Vadodara GUJARAT 
 
Primary Sponsor  
Name  Dean Faculty Of Ayurved Parul University 
Address  Parul ayurved hospital,parul university campus AP Limda Tal Waghodia Vadodara GUJARAT 
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 Hetvi Dabhi  Parul Ayurveda Hospital  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital,Limda,Waghodia road Vadodara-391760
Vadodara
GUJARAT 
9016988782

dr.hetvidabhi03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
parul institute of ayurved-institutional ethics committee parul institute of ayurved parul university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: nano kanchnar, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: 2.5gm per day
2Comparator Arm (Non Ayurveda)-placebomedicine name:placebo,reference:NA,route:oral,dosage form:gutika/vati/ghana vati/tablets,dose:2.5(g),frequency:bd,bhaishajya kal:adhobhakta,duration:3 months,anupana/sahapana:yes(details:water),additional information:2.5gm per day
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) Age: From 18 Year(s) Age To 60 Year(s) (inclusive of either age)
b) Gender: Both
c) Patients already diagnosed as hypothyroidism with/without medication
d) Patients with primary hypothyroidism
e) Patients with subclinical hypothyroidism 
 
ExclusionCriteria 
Details  a) Patients who have undergone any type of thyroid surgery.
b) Patients suffering from systemic diseases like IHD, PCOD, uncontrolled Diabetes Mellitus, uncontrolled
HTN
c) Immuno compromised diseases like HIV etc.
d) Patients suffering from congenital hypothyroidism
e) Pregnant and lactating women 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to study adjuvant effect of nano Kanchnar (Bauhinia variegata Linn) hydro-alcoholic
extract in comparison with placebo on the basis of T3,T4,TSH levels in management of hypothyroidism 
T3,T4,TSH levels at baseline and at the 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
to study adjuvant effect of nano Kanchnar (Bauhinia variegata Linn) hydro-alcoholic
extract in comparison with placebo on the basis of standard gradation scale and Billewicz index for hypothyroidism in management of hypothyroidism at 4weeks,8weeks,12weeks. 
lipid profile at baseline and at the 12 weeks

billewicz index for hypothyroidism at baseline and at the end of every visit. 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/11/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hypothyroidism is a disorder that occurs when the thyroid gland does not make enough thyroid hormones to meet the body’s need. The thyroid hormone regulates metabolism—the way the body uses energy— and affects nearly every organ in the body. Without enough thyroid hormone, many of the body’s functions slowdown.

There is no direct description of hypothyroidism in Ayurveda but on the basis of its clinical presentation hypothyroidism can be correlated with dhatwagnimandya (ras and meda dhatwagnimandya). Samprapti Ghataka’s are Kapha Dushti, Dhatwagnimandya, Jatharagni Dushti Rasavaha - Medovaha Sroto- Dushti found mainly. So, Hypothyroidism is a Santarpanjanya Vyadhi

Kanchanara reduce the swelling of neck, increased serum thyroid hormone concentration, decreased Cholestrol and improve Thyroid histology Kanchnar is considered as a drug of choice for Granthi vikar and Galaganda, hence for the present study hydroalcoholic extract Kanchnar Twak is selected. Kanchnar stem bark has been investigated and reported to have anti-tumor property. Kanchnar extract, as standardized extracts, provide unlimited opportunities for uncovering new drug because of the unmatched availability of chemical diversity.

It is expected that by using Nano particles bioavailability, effectiveness is enhanced. The dosage of drug which is difficult to take will be reduced without reducing the quality and effect of the drug. As this will be a new dosage form of B.variegata stem bark, safety and efficacy which is established by previous studies in animal models, will be evaluated in cases of hypothyroidism.May increase bioavailability, easily palatable, effectiveness is more Reduced exploitation of plants as the size of herbal medicine is reduced. Increase the therapeutic value by reducing toxicity level of the drug.

 
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