| 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 |
|
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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 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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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 | | 2 | Comparator Arm (Non Ayurveda) | | - | placebo | medicine 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 |
|
|
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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. |