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CTRI Number  CTRI/2023/10/058711 [Registered on: 16/10/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
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   To Study Add On Effect Of Varunmoola Kwath Ghana Vati With Thyroxine In Hypothyroidism. 
Scientific Title of Study   A Randomized Controlled Clinical Study To Evaluate Add On Effect Of Varunmoola Kwath Ghana Vati With Thyroxine 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  Dr Ankush Rajkumar Patle 
Designation  PG Scholar 
Affiliation  PDEAs Of Ayurved And Research Centre Nigdi PuneCollege  
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  7028880058  
Fax  0  
Email  ankushpatle27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Medha M Joshi 
Designation  Professor & HOD 
Affiliation  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune  
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  8104332338  
Fax  0  
Email  medhamaheshjoshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Medha M Joshi 
Designation  Professor & HOD 
Affiliation  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune  
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411044
India 
Phone  8104332338  
Fax  0  
Email  medhamaheshjoshi@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Center nigdi pune 
 
Primary Sponsor  
Name  PDEAs College Of Ayurved And Research Centre Nigdi Pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India 
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 Ankush Patle  Ayurved Rugnalaya And Sterling Multispeciality hospital Pune  Ayurved Rugnalaya And Sterling Multispeciality hospital Sector No 27 Kayachikitsa Department Opd no 117 Nigdi Pradhikaran Pune 411044
Pune
MAHARASHTRA 
7028880058
0
ankushpatle27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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: RASAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Varunmoola Kwath Ghanavati , Reference: Vangasen Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madh), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Diagnosed cases of Hypothyroidism on the basis of TSH Levels (TFT will be done)
2) Patients S.TSH level above normal value and involving symptoms of hypothyroidism from subjective criteria (puffiness of face, oedema, dry and coarse skin, breathlessness, constipation, fatigue, hair fall)
3) Age between 20 to 60 years. 
 
ExclusionCriteria 
Details  1)Pregnancy, lactating mother
2)patient having associated diseases as ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes, known case of MI, Cerebrovascular events, cardiac arrhythmias, malignancy, hyperthyroidism
3) patients with any known infective disease
4) known case of major systemic diseases such as TB, AIDS, IHD, CA, Renal and cerebral diseases, thyroid CA, partial thyroidectomy, congenital thyroid disorders and other major endocrinal disease, morbidly obese patients 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To Study efficacy of Varunmoola kwath Ghanavati with Thyroxine in the management of hypothyroidism for 60 days.
2.To give maximum symtomatic relief to patient after 60 days of treatment.  
60 days study with four follow ups on 15th,30th,45th and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe adverse drug reaction if any.  60 days study
follow up at 15th, 30th, 45th 60th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/10/2023 
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="0"
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  
 Non Communicable diseases are the leading cause of adult mortality and morbidity worldwide. Hypothyroidism is a metabolic disorder as it involves the underproduction of hormones that play a role in metabolism  Hypothyroidism is believed to be a common health issue in India, as it is worldwide. The most common presentations of thyroid disorders are hypothyroidism, hyperthyroidism,and enlargement if thyroid gland. widespread availability of thyroid function tests has led to the increasingly frequent identification of patients with abnormal results who either are asymptomatic or have non-specific complaints such as tiredness and weight gain.Untreated hypothyroidism can lead to a number of health issues, Heart problems, Mental health   issues (Depression), Peripheral neuropathy, Myxoedema, Infertility, Birth defects3.  42 million people in India have thyroid disorders and hypothyroidism is the most common of thyroid disorders in India, affecting one in ten adults.The prevalence of hypothyroidism in India is 11%, compared with only 2% in the UK and 4·6% in the USA4.Over 8% of Indian is at a higher future risk of getting affected, and 1/3rd of the hypothyroid patients is unaware of the condition Reduced Production of thyroid hormone is the central feature of the clinical state termed hypothyroidism. Primary hypothyroidism which is due to disease of thyroid itself ,accounts for approximately 99% of cases, with  less than 1% being due to TSH deficiency known as central or secondary hypothyroidism.In adult hypothyroidism clinical features can largely be explained by the reduced metabolic rate and symptoms of hypothyroidism develop gradually. Skin is pale and cool and
reduction in sweat and sebaceous secretion causes dryness and coarseness, decrease in exercise tolerance , cold intolerance, weight gain. In modern medicine the treatment for hypothyroidism is the administration of thyroxine in the form of tablet, orally. Acharya Charak emphasized that nomenclature of the diseases is not much important to treat the diseases, rather he insists on diagnosis of the constitutional status and plan the treatment accordingly.  On reviewing the clinical presentation from all classical texts it is found that in hypothyroidism there is abnormality of Jatharagniand Dhatwagni along with abnormality of Kapha and VataDosha as well as Rasavaha, Raktavaha,Medovaha, Shukravahaand Manovaha Srotases. Dosha-Dushyasamoorchhana in various Dhatus results in the systemic manifestation of the disease. Thus, the line of treatment involves Deepana, Pachana, SrotoshodhanaandKaphavata shamana8.  At this present moment hormone replacement therapy is available for hypothyroidism, there is and there is need of time to find proper and efficient supportive Ayurvedic  treatment modality for hypothyroidism ,Therefore i Have select this topic. For that I have choose to give VarunmoolaKwath GhanaVati orally along with Thyroxine. Thyroxine is used to treat an underactive thyroid gland (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland9, Therefore it will be taken as a control group.
This varunmoola kwath ghanvati described in vangasen samhita.
 
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