FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078336 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with Levothyroxine in the management of Primary Hypothyroidism 
Scientific Title of Study   An Open Randamised Controlled Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with levothyroxine in the management of Primary 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 Pranay Omprakash Gundewar 
Designation  PG Scholar 
Affiliation  R.A. Podar hospital, worli 
Address  OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

Mumbai
MAHARASHTRA
400018
India 
Phone  8308068834  
Fax    
Email  pranaygundewar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunil Anandrao Bhaskare 
Designation  Associate Professor 
Affiliation  R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 
Address  OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

Mumbai
MAHARASHTRA
400018
India 
Phone  9819165638  
Fax    
Email  bhaskaresunil14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr sunil Anandrao Bhaskare 
Designation  Associate Professor 
Affiliation  R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 
Address  OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

Mumbai
MAHARASHTRA
400018
India 
Phone  9819165638  
Fax    
Email  bhaskaresunil14@gmail.com  
 
Source of Monetary or Material Support  
OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 pin code-400018 
 
Primary Sponsor  
Name  R A Podar Govt (Ayu) Collage,Worli,Mumbai-18 
Address  R A Podar Govt (Ayu) Collage,Worli,Mumbai-18 Dr.Anie Besant Road Pin code-400018 
Type of Sponsor  Government 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 Pranay Omprakash Gundewar  Mahadevi Anandilal Podar Govt Hospital  OPD No.18,Kayachikitsa Department,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18,Dr Anie Besant Road, Pin code-400018
Mumbai
MAHARASHTRA 
08308068834

pranaygundewar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS Committee of institution,R A Podar Govt Ayu collage,Worli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: RASAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Varunadi gutika, Reference: Ashtanga hrudaya sutrasthana , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -koshnajala ), Additional Information: -
2Comparator Arm (Non Ayurveda)-Levothyroxine Dose:1.6mcg/kg for 3 months OD
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Signs and symptoms of primary hypothyroidism- gauravata, nidradhikya, agnimandya, Shram, khalitya.
2) Subjects who are willing to give written informed consent.
3) Serum T3 and T4 within normal range and Serum TSH level above 5.5µU/ml but
below 20 µU/ml.
 
 
ExclusionCriteria 
Details  1)Secondary hypothyroidism, itrogenic hypothyroidism, post thyroidectomy.
2)Pregnant & lactating mothers
3)Uncontrolled Hypertension, Diabetes Mellitus, IHD, CVA.
4)Malignancy of Thyroid Gland
5)Any other metabolic or systemic disease conditions where other treatment is urgent
and was disturb the regimen. (HIV, Diabetes Cardiovascular disease, Tuberculosis etc.)
6)Patient having myxoedema coma.
7)Patients having Down’s syndrome, Turner’s syndrome, Klinefelter’sSyndrome will be
excluded.
8)Present history of any mental disorder.
9)Patient with acute and chronic gastritis, PR bleeding. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To study the effect of ‘Varunadi Gutika’ As an adjuvant therapy with
levothyroxine on Kshudhamandya (poor appetite), Malavstambha(constipation),
Shram(lethargy), gauravta (heavyness of the body), Khalitya (hairloss), Nidradhikya
(increased sleep), etc. symptoms of primary hypothyroidism.
2.To study the effect of Varunadi Gutika as an adjuvant therapy with levothyroxine
on serum TSH T3, T4 level 
For 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To review the Ayurvedic & Modern literature on Primary Hypothyroidism.
2)To correlate Rasdhatvagnimandya,Rasapradoshjanya vyadhi & Primary Hypothyroidism.
3)To assess the possible mode of action of Varunadi Gutika 
At 4th 8th & 12th week 
 
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   Phase 3 
Date of First Enrollment (India)   27/12/2024 
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   Ayurveda is one of the ancient health care system. Ayurveda promotes specific lifestyle changes and natural treatments to restore harmony between the body, mind, spirit, and environment. Ayurveda is a holistic tradition and way of life that can assist each of us In claiming and celebrating our ability for wellness. The guiding principles of Ayurveda, maintaining health in all situations and eras, justifies current requirements for past uses. Due to an increase in sedentary and unhealthy lifestyles, many people nowadays
experience numerous metabolic problems, including primary hypothyroidism. Hypothyroidism is one of the burning issue now a days. An unusually low thyroid hormone level is one of the symptoms of hypothyroidism. It happens when the thyroid gland does not produce enough thyroxine. Each organ in the body may be impacted by thyroxine’s control over how the body uses energy. Thyroxine deficiency causes the body’s functions to slow down. It affects nearly every bodily function, therefore maintaining a healthy level of thyroid hormone is essential for good health. The prevalence rate of hypothyroidism in Mumbai is 9.45%. Thyroid disease affects women more often than men and affects roughly 5% of the population. Womens are affected approximately six time more frequently than men. Ayurveda states that the pathophysiology of hypothyroidism is mostly caused by agni’s improper activity. It can be correlated to the concept of mandagni in ayurveda. The pathogenesis process is eventually shown by abnormal jatharagni functioning, which then affects dhatwagni and, ultimately, results in the disease condition.
Varunadi Gutika is a combination of 09 drugs, which are Varun, Bruhati, Kanthakari, Chitrak, Bilva, Shobhanjan, Shatavari, saireyak, karanja. All these drugs have Ushna, Tikshna, Deepana, Pachana and Grahi properties therefore it will reduce the symptoms of hypothyroidism comparing to ’mandagni’

Need of study:
For the treatment of primary hypothyroidism, an efficient pharmaceutical preparation is required. As the hormone replacement therapy is only available way to treat the condition. There is flaw in this conventional treatment because it required prolonged use. With the chronicity of the disease, the gland functioning never improves, instead they become more and more inactive. Taking above in consideration, I have chosen my synopsis under title, “An Open Randomised Controlled Clinical Study to evaluate the efficacy of Varunaadi gutika as an adjuvant therapy with Levothyroxine in the management of primary hypothyroidism."

Number of patient-
Group A: Study group -30 patient will be administered Varunadi gutika along with
Levothyroxine.
Group B: Control group-30 patient will receive only Levothyroxine.

Investigations-
CBC, ESR, BSL fasting and PP, Liver Function and Renal Function Test, Lipid Profile to exclude any Pathology.
Thyroid function test , BSL and Lipid profile will be estimated before and after treatment.

Summary and Conclusion:
The work will be summarized to make final conclusions Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.

Expected outcomes:
• Changes in subjectives by ’Varunadi Gutika’ towards reduction in previous severity.
• Changes in Thyroid profile by ’Varunadii Gutika’ towards reduction of Sr.TSH in previous high levels.
• Effect of ’Varunadi Gutika’ could be more than the effect of Tab.Levothyroxine without any adverse effects.





 
Close