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CTRI Number  CTRI/2025/03/081814 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Other (Specify) [Nasya Karma]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Nasya ( Nasal Instillation) with Katutumbi Taila and Rasapachaka yoga in the management of Hypothyroidism. 
Scientific Title of Study   An Open Labelled Active Controlled Randomised Clinical Evaluation Of Nasya With Katutumbi Taila and Rasapachaka Yoga In The Management Of 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 Pooja Vekaria 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8140374731  
Fax    
Email  vekariapooja206@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dipeeka Surwase 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9860750957  
Fax    
Email  drdipeeka77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dipeeka Surwase 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India


GUJARAT
391760
India 
Phone  9860750957  
Fax    
Email  drdipeeka77@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of Ayurved,Parul University,AP-Limda, TAL-Waghodia,Vadodara,Gujarat, India-391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Faculty of Ayurved, Parul University, AP-Limda, TAL-Waghodia, DIST-Vadodara, Gujarat, India-391760 
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 Pooja Vekaria  Parul Ayurved Hospital  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP-Limda TAL-Waghodia Vadodara Gujarat 391760 India
Vadodara
GUJARAT 
8140374731

vekariapooja206@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasya with Katutumbi Taila and Rasapachaka yoga  Katutumbi Taila: Reference:Yogratnakar Nidanasthana chapter 11/49 Route:Nasal Dosage Form:Taila for Nasya for 7 days Dose:6-6 drops Frequency:od Bhaishajyakal:Abhakta Duration:60 days Anupana/Sahapana:- Rasapachaka Yoga: Reference:Charak Samhita chikitsa sthana chapter 3/200 Route:oral Dosage Form:vati for 23 days Dose:4 tab (500 mg) Frequency:Bd Bhaishajyakal:Adhobhakta Duration:60 days Anupana/Sahapana:- water 
Comparator Agent  Tablet Thyrox   Ongoing medicine Drug form: Tablet Route:Oral Time:Empty Stomach Duration:60 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of either gender between age group 20 to 60 years.
Patient already diagnosed as hypothyroidism with or without medication as well as newly diagnosed.
Patient fulfilling the criteria of diagnosis according to billewicz diagnostic index and zulewski clinical score for hypothyroidism.
Patient with serum TSH value greater than 4.5 microIU per ml.
Patient with total serum T4 and total serum T3 value less than normal value and within normal value.(Total serum T4 is 4.5 to 12.5 microgram per dl and Total serum T3 is 80 to 220 nanogram per dl). 
 
ExclusionCriteria 
Details  Patients who have undergone any type of thyroid surgery.
Patients suffering from Hashimoto’s thyroiditis.
Patients suffering from immunocompromised diseases.
Patients with active infective diseases like Tuberculosis, Hepatitis B.
Pregnant and lactating women.
Patients who are currently participating in any other clinical trials (since last 2 months).
Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of T3, T4, TSH and LIPID PROFILE.  T3, T4, TSH and LIPID PROFILE-On the screening visit and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of subjective parameters.  On the screening visit, 15th day, 30th day and 60th day 
To study the safety of Nasya with Katutumbi taila and Rasapachaka yoga in
patients of hypothyroidism.
 
On the screening visit, 15th day, 30th day and 60th day 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 
Date of First Enrollment (India)   01/04/2025 
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 - NO
Brief Summary  

Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones, leading to a wide range of metabolic, physiological and psychological disturbances. There is no direct description of hypothyroidism in Ayurveda but based on its clinical presentation hypothyroidism can be correlated with Galaganda. In ayurveda, Galaganda occurs when there is vitiation of kapha and Vata doshas, predominantly Kapha which further results in a disturbance of Meda and Majja dhatus, resulting in the formation of Galaganda. The thyroid gland is situated in Urdhwajatrugata Sthana, which is a Kapha Sthana, for elimination of Kapha, Shirovirechana has been described by Acharyas. Hence the management of hypothyroidism by Nasya may be a better choice. Nasya has a direct influence on the functioning of the thyroid gland. Hence in the current study, it is proposed to evaluation of both Shodhana – Nasya with Katutumbi Taila and Shamana- Rasapachaka yoga in comparision with standard control in the management of Hypothyroidism. This study focus on early screening and assessment of  hypothyroidism through T3, T4,TSH, LIPID PROFILE and Billewicz diagnostic index and Zulewski clinical score as well as management of hypothyroidism through Nasya followed by Rasapachaka yoga. Katutumbi taila and Rasapachaka yoga preparation will be done. Pharmacological evaluation and standardization through GCMS, LCMS and  HPTLC. In trial group Nasya will be done for 7 days followed by Rasapachaka yoga given in dosage of 2 gm BD for 23 days, this cycle will be repeat in next month while in control group Tablet Thyrox given in morning at empty stomach.

 
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