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CTRI Number  CTRI/2024/09/073875 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the Efficacy of Vyoshadi Guggulu and Katutumbhi Taila Nasya in Hypothyroidism 
Scientific Title of Study   A Randomized Control Trial Of Vyoshadi Guggulu And Katutumbhi Taila Nasya Along with Levothyroxine In Hypothyroidism w.s.r. Thyroid Stimulating Hormone 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pallavi Vasant Valvi 
Designation  PG Scholar  
Affiliation  Government Ayurveda College And Hospital Nagpur  
Address  Department of Kayachikitsa OPD No.1 ,Government Ayurveda College And Hospital ,Sakkardara Square ,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  7039484302  
Fax    
Email  sonyvasantvalvi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayant Gulhane  
Designation  Associate Professor  
Affiliation  Government Ayurveda College And Hospital Nagpur  
Address  Department of Kayachikitsa OPD No.1 ,Government Ayurveda College And Hospital ,Sakkardara Square ,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9822922399  
Fax    
Email  jayant.gulhane.62.6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jayant Gulhane  
Designation  Associate Professor  
Affiliation  Government Ayurveda College And Hospital Nagpur  
Address  Department of Kayachikitsa OPD No.1 ,Government Ayurveda College And Hospital ,Sakkardara Square ,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9822922399  
Fax    
Email  jayant.gulhane.62.6@gmail.com  
 
Source of Monetary or Material Support  
OPD No.1 Kayachikitsa Department, Government Ayurveda College and Hospital Nagpur pincode 440024 ,Maharashtra ,India  
 
Primary Sponsor  
Name  Pallavi Vasant Valvi  
Address  Government Ayurveda College and Hospital, Sakkardara Square Nagpur 440024 
Type of Sponsor  Other [Self] 
 
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 Pallavi Valvi  Government Ayurveda College and Hospital Sakkardara Square Nagpur 440024  OPD no 1 Department of Kayachikitsa
Nagpur
MAHARASHTRA 		 7039484302

sonyvasantvalvi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda College And Hospital Nagpur   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: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Bhaishajya Ratnavali Page No 44-69, Procedure details: Katutumbhi Taila nasya for 21 days OD in dosage of 8 drops in each nostrils in morning session. pre procedure includes local massage & steam fomentation to the face. post procedure includes gargles and face cleaning with luke warm water. avoid cold food, air , drinks after an hour of procedure.)
(1) Medicine Name: Vyoshadi Guggulu, Reference: Ashtang Hriday Chikitsasthan Chapter No 21, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 30 Days
2Comparator Arm (Non Ayurveda)-LevothyroxinePatients with levothyroxine 25 mcg 50 mcg 75mcg 100 mcg orally once a day before meal for 30 days as per physician dose will be considered in the trial
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient on TSH value above 5 mIu/L
Patient having clinical features of hypothyroidism and fulfilling diagnostic criteria of this study Patients who are willing to participate in trial and ready to give written consent
Patients of either sex aged between 18-60 years irrespective of caste religion socioeconomic and educational status
Patient with controlled HTN BP Systolic less than 150 and Diastolic less than90 mmHg and DM having FBS more than 130 mg/dl and PMBS more than 200 mg/dl
Patients who are fulfilling the criteria of clinical hypothyroidism score more than 5 according to Zulewsks scale
Patient fit for Nasya karma 
 
ExclusionCriteria 
Details  Patients who are suffering from Congenital Hypothyroidism Neoplasia Toxic Goitre
Patients who had undergone any type of Thyroid surgery
Patients who are not willing to participate in trial and not ready to give written consent Patients having age below 18 years and above 60 years
Pregnant women and Lactating mother
Patients on prolonged medication more than 6 week with corticosteroids or any drug that may had an influence on the outcome of study
Patients who are currently participating in any other clinical trial from last 6 months
Patients who has uncontrolled HTN BP Systolic more than 150 Diastolic more than 90 mmHg DM FBS more than 130 mg/dl and PMBS more than 200 mg/dl or any other systemic illness
Patient Unfit for Nasya Karma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Evaluate The Efficacy Of Vyoshadi Guggulu and Katutumbhi Taila Nasya
Along With Levothyroxine In The Management of Hypo - thyriodism w.s.r Thyriod Stimuting Hormone Levels over 30 days of time span. 		 On 0th day ,15 th day ,30 th day  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of Vyoshadi Guggulu & Katutumbhi Taila Nasya along with levothyroxine in Hypothyriodism on Zulwesk’s scale.
2. To Study Hypothyroidism & its Ayurvedic perspective over 18 months. 		 On 0 th day 15 th day 30 th day  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   23/09/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonyvasantvalvi@gmail.com].

  6. For how long will this data be available start date provided 23-09-2024 and end date provided 23-09-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After clearance of institutional ethics of Government Ayurveda college Nagpur screening of population will be done from patient in OPD, IPD and casualty of our institute. In clinical study of 70 patients of Hypothyroidism will include. If patients fulfill the criteria of inclusion, subject would also given freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in the study.
The treatment will be given to patient as follow:
Assessment on Zero day
Trial Group :
1.Vyoshadi Guggulu 500 mg BD Before meal for 30 days. 2.Katutumbhi Taila Nasya 8 drops each nostrils for 21 days once in morning . 
Control Group :
Tab. Levothyroxine ( directed as per
by Physician )
 Assessment on day 15
Assesssment after 30 days
Assessment for the subjective and objective criteria after treatment. 
1.Medium of Dissertation: The dissertation will be written in English and Sanskrit will be used wherever necessary.
2.Study Design: Randomized Controlled Trial
3.Duration of study: 18 months. 
4.Duration of Treatment: 30 days
5.Ethical Clearance: Clearance from Institutional Ethics committee of our institute.
6.Study setting :OPD, IPD and casualty of our institute and its periphery.
7.Duration Of study:Study will start after approval of synopsis from BORS till the completion of sample size. Maximum expected duration is 18 Months.
Subjective and Objective parameters will be considered to evaluate the effect. For this following parameter will be measured. A) OBJECTIVE CRITERIA :
A] ANTHROPOMETRIC CHARACTERS
1. Weight
2. Height
3. BMI
B] CLINICAL PARAMETERS:
1. Blood Pressure
2. Pulse rate
3. Respiratory Rate
4. Spo2
5. Temperature
B) Biochemical parameters:
1.Thyroid Function Test (T3, T4, TSH)
IF Necessary, 1.Complete blood count
2.Urine routine and microscopic
3.BSL fasting and post meal.
4.Lipid Profile 
B) Subjective Criteria
The assessment of signs and symptoms will be carried out by following scales. 
1.Zulewsk’s Clinical score of Hypothyroidism on 0 th day 15 th day and 30 th day.
Study Population:
1.All the patients attending OPD, IPD and Casualty of our institute will be
considered in this study. 
2. Patients in between age group of 18 – 60 years.
3. Patient fulfilling the diagnosatic criteria
Sample Size :
It is estimated based on efficacy of Vysohadhi Gugglu and Katutumbhi Taila Nasya with Levothyroxine reported in published article “A comparative clinical study on the efficacy of Nityanand Ras with (or) without Jeernakarkaruka
Nasya in Hypothyroidism” with following assumptions. 
1. % effect of Vysohadhi Gugglu and Katutumbhi Taila Nasya= 51.5%
2. % effect of Levothyroxine = 47.22%
3. Power (1-β)% = 80
4. α-error = 10
5. Required sample size in each group is 32. Considering 10% dropout/non- response, Hence Final sample size is 35 per group. 
A.In Trial Group-Vyoshadi guggulu and Katutumbhi Taila Nasya with
Levothyroxine . 
B.In Control Group-Levothyroxine
 
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