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CTRI Number  CTRI/2024/12/077600 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Management of Dhatvagnimandya Vikrati(Hypothyroidism)Through Ayurveda 
Scientific Title of Study   An Exploratory Study to Evalauate the Combined Efficasy of Sinduthaadi Modaka and Nasya of Katutumbi Taila in the Management of Dhatvagnimandya Vikrati (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 GUDDI 
Designation  PG SCHOLAR 
Affiliation  post graduate institute of ayurved, jodhpur 
Address  P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India RAJASTHAN 342037 India
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India 
Phone  6376134174  
Fax    
Email  guddipanwar6376@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR BRAHMANAND SHARMA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  post graduate institute of ayurved, jodhpur 
Address  ROOM NO 118 PG DEPARTMENT OF KAYACHIKITSA POST GRADUATE INSTITUTE OF AYURVED DR S R RAJASTHAN AYURVED UNIVERSITY JODHPUR RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9460318138  
Fax    
Email  bkmudgal9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GUDDI 
Designation  PG SCHOLAR 
Affiliation  post graduate institute of ayurved, jodhpur 
Address  P.G. Department of Kayachikitsa, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved

Jodhpur
RAJASTHAN
342037
India 
Phone  6376134174  
Fax    
Email  guddipanwar6376@gmail.com  
 
Source of Monetary or Material Support  
post graduate institute of ayurved jodhpur Rajasthan India 342037 
 
Primary Sponsor  
Name  post graduate institute of ayurved jodhpur 
Address  P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DR GUDDI  P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR GUDDI  post graduate institute of ayurved jodhpur  P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN 
6376134174

guddipanwar6376@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE POST GRADUATE INSTITUTE OF AYURVED JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Sindhuthaadi Modaka, Reference: Chakrdatta, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing for the trial.
Patients between the age of 18-60 years of either sex.
Patients who are newly diagnosed of Hypothyroidism with increased TSH levels.
Subjects coming with chief complain of unexplained weight gain cold intolerance constipation
hoarseness of voice fatigue depression edema.
Subjects detected with TSH between 5-20 Miu/L 
 
ExclusionCriteria 
Details  Patients below the age of 18 years and above 60 years.
Patients suffering from congenital hypothyroidism and secondary hypothyroidism hypertension.
Subject having multi neoplasm toxic goiter is excluded.
Patients who have undergone any type of thyroid surgery.
Pregnant and lactating women are excluded.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Assessment Of Subjective And Objective Parameters Before And After Treatment  90 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
To observe any side effects if occur during
clinical trial 
90 DAYS 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   13/12/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
INTRODUCTION 
Hypothyroidism is the most common endocrinal disorder that occurs when the thyroid gland does not make enough thyroid hormone to meet the body’s needs. Thyroid gland produces two hormones Thyroxine (T4) & Triiodothyronine (T3). These hormones play a critical role in cell differentiation during development and help maintain thermogenic and metabolic mechanism. Thyroid hormone regulates the metabolism and affects nearly every organ in the body. Without enough thyroid hormone, many of the body’s functions slow down. It is based on belief, that health and wellness depend on a delicate balance between the mind, body and spirit. In the changing lifestyle of 21stcentury hypothyroidism is considered as one of the commonest diseases. Hypothyroidism is the major endocrine disorder seen in general population. It is characterized by the deficiency of thyroid hormones to abnormal levels. This condition leads to the reduction in Basal metabolic rate, affects physical and mental growth during infancy or childhood. The dysfunctioning of the ’Agni’ is the basic cause of the clinical manifestations of Hypothyroidism. The hypofunctioning of jatharagni’ in turn affects "Dhatwagni" which acts as the basic factor for the occurrence of the diseased condition In Ashtanga Hridaya, Vagbhata emphasizes the importance of Kayagni and its direct implication on the status and maintenance of the Dhatwagni, the Vriddhi/Kshina Avastha of the Jatharagni would result in the same status of Dhatvagni too. Kayagni present in its own place, has portions of itself, pre- sent in the Dhatus also. Their decrease (in quantity, qualities or functions) and in- crease (in quantity, qualities or functions) give rise to increase and decrease of the Dhatus (respectively). If preceeding Dhatu is increased or decreased, it will increase or decrease the succeeding Dhatu too. Ayurveda is named as the science of life. It is one of the world’s oldest holistic healing system. In Ayurvedic classics hypothyroidic problems are not described under a particular disease. On the basis of Ayurvedic principles, we can understand the pathology of Hypothyroidism as that “Roga Sarveapi Mandagno”. In modern terminology “Agnimandya” can be understood as decreased caloric expenditure which is present at systemic and cellular level. It is basically caused due to dysfunctioning of the Agni. It is a metabolic disorder in which Agni (Jatharagani, Bhutagni, Dhatwagni) are at very low level. Vriddhi of Vata Dosha and Kapha Dosha and Kshaya of Pitta is most important in genesis of disease Hypothyrodism.Many of Rasa Pradoshaja Vikaras which have been mentioned in Charak Samhitaare similar to the clinical features of Hypothyroidism i.e. Ashraddha, Aruchi, Gaurava, Tandra, Angamarda, Panduroga, Klaibya, Srotorodha, Agnimandya etc.

METHOD OF PREPARATION OF TRIAL DRUG Drug A: Sinduthaadi modaka – All the ingredients are taken in equal quantity and a fine powder is prepared and jaggery is added equal to all 4parts drugs taken and modaka is prepared. Drug 
B: Katutumbi taila – All the ingredients are taken in equal amount and a fine paste is prepared. Before preparation of medicated taila the crude Taila should have processed with a special procedure. Tailais heated till it becomes free from froth. 4 part of water is added along with 1 part of paste. It is boiled on moderate heat till oil becomes free from water then oil is filtered. When all the darva dravayas have evaporated the moisture in kalka will also begin to evaporate at this stage. It has to be stirred more oftenand carefully to ensure paste does not stick. 
 
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