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CTRI Number  CTRI/2024/05/067097 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial with intervention of Agni Kumar Rasa and Maha Ajmodadi Taila Nasya in Subclinical Hypothyroidism patients.  
Scientific Title of Study   A Randomized Comparative Clinical Trial on Efficacy of Agni Kumar Rass and Maha Ajmodadi Taila Nasya in Subclinical Hypothyroidism With Special Reference to Agnimandhya.  
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 Hemanta Gautam 
Designation  PG Scholar, Dept. of Shalakya. 
Affiliation  NIA, Jaipur. 
Address  Rajasthan, Jaipur, jorawar singh gate, 302002, Agnivesh PG Boys Hostel, room no.111

Jaipur
RAJASTHAN
302002
India 
Phone  7877366193  
Fax    
Email  gautam.baruag1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Shamsa Fiaz 
Designation  HOD and Professor, Department of Shalakya Tantra (Guide of this study) 
Affiliation  NIA, Jaipur. 
Address  Rajasthan, Jaipur, jorawar singh gate, NIA, Shalakya Department, room no.319
NIA, Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  8764009846  
Fax    
Email  shamsa_fiaz@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Shamsa Fiaz 
Designation  HOD and Professor, Department of Shalakya Tantra (Guide of this study) 
Affiliation  NIA, Jaipur. 
Address  Rajasthan, Jaipur, jorawar singh gate, NIA, Shalakya Department, Room no.319
NIA, Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  8764009846  
Fax    
Email  shamsa_fiaz@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Ayurved, Research fund, Rajasthan, Jaipur, 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda, Jaipur 
Address  Rajasthan, Jaipur, jorawar singh gate, 302002 
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 
Prof Shamsa Fiaz  National Institute of Ayurveda  Rajasthan, Jaipur, jorawar singh gate, 302002, Shalkya Department, OPD no: 13 and 14
Jaipur
RAJASTHAN 
8764009846

shamsa_fiaz@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Maha ajmodadi taila, Reference: Vangasen samhita chapter no: 47, Shloka no:12-17, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Dhumpan), Additional Information: -Nasya will be carried out for three sittings of 7 days with the gap of 3 days in between.
2Comparator ArmDrugClassical(1) Medicine Name: Agnikumar ras, Reference: Bhaisajya ratnawali chapter no:10, shloka no: 115-116, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -hot water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with subclinical hypothyroidism with TSH levels ranging from 4.5µIU/ml - 15µIU/ml,
and T3 and T4 within normal limit. 
 
ExclusionCriteria 
Details  Patients suffering from congenital hypothyroidism, overt and secondary hypothyroidism.
⮚ Patients of hyperthyroidism, neoplasia, and toxic goitre are excluded.
⮚ Patients who have undergone any type of thyroid surgery.
⮚ Patients suffering from systemic diseases like cardiac problems, uncontrolled diabetes,
hypertension, carcinomas, chronic renal disease, chronic liver disease.
⮚ Patients taking drugs known to alter thyroid hormone level (e.g., Amiodarone)
⮚ Patients who are pregnant or expecting pregnancy in next six months.
⮚ Recent hospitalization for major illness, to exclude with ESS (Euthyroid Sick Syndrome). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in TSH level.  At baseline, 30th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in the symptoms of mandagni.
2. Change in general sign & symptoms associated with subclinical hypothyroidism.
3. Reduction in body weight & BMI. 
1ST DAY, 30TH DAY AND FOLLOW UP AFTER 1 MONTH I.E. 60 TH DAY OF ENROLLMENT. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/05/2024 
Date of Study Completion (India) 18/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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: 
 Thyroid disorders have become very common in India as well as globally and according to various studies about 42 million people in India are suffering from these disorders. Early diagnosis and treatment remains the corner stone of management. The thyroid may be primary if the pathology exists in thyroid gland, secondary if it is in pituitary and tertiary if the pathology lies in hypothalamus. Hypothyroidism is commonly caused due to changes in dietary habits, sedentary lifestyle, stress, smoking, family tendency etc. Hence hypothyroidism is second to Diabetes mellitus is prevalence as the most common endocrine disorder. The symptoms of hypothyroidism are tiredness, excessive weight gain, cold intolerance, muscle pain, stiffness, edema including periorbital edema, hair loss, hoarseness of voice, constipation, depression etc. Thyroid hormones play a very important role in our body’s metabolism. Its functions are similar to the those of Agni. According to Ayurveda, the function of thermogenesis and metabolism in the body is principally related to Agni. If Agni of a person is vitiated whole metabolism of the body will get disturbed and it will give rise to various diseases. In Ayurveda, clinical manifestations of subclinical hypothyroidism can be considered as a state of dominance of Kapha associated with Margavaranajanya Vataprokopa. Hence we can indirectly relate hypothyroidism to Agnimandhya. More ever there are many diseases which are not mentioned directly in Ayurveda texts and hence are considered as Anukta vikara and thyroid disorder can also be included under the same. Galaganda can also be considered under Hypothyroidism based on its symptoms. As Ayurveda has shown a promising outcome in different metabolic disorders, different clinical studies has shown a significant benefit in subclinical hypothyroidism through Ayurvedic oral medicinal treatment. But no studies are published or done with the intervention of nasya in the management of hypothyroidism. Although very few review articles are published regarding nasya in hypothyroidism. Subclinical hypothyroidism (SCH) is biochemically defined as an elevated level of thyroid stimulating hormone (TSH) with normal level of free thyroxine (FT4) in the blood with minimal or no signs and symptoms of thyroid dysfunction. The most common cause of subclinical hypothyroidism is chronic autoimmune thyroiditis associated with antithyroid peroxidase antibodies (Hashimoto’s thyroiditis) but it can also occur due to other causes. Subclinical hypothyroidism (SCH) can be classified as Mild Grade 1 when upper limit of TSH is 9.9 mIU/L and severe grade 2 when TSH ≥10mIU/L. Where in patients are asymptomatic, but clinical manifestations similar to overt hypothyroidism are present in milder form.3 Several meta-analyses of observational studies have revealed an association between SCH and coronary artery diseases. -* Studies have reported prevalence of hypothyroidism in India as 10.95% being highest in the age group of 46 to 54 years (13.11%) and lowest in 18 to 35 years (7.53%) and that of SCH being highest (8.93%) in persons above 55yrs and lowest (6.91%) in age group of 18-35yrs. The risk of progression from SCH to overt hypothyroidism is 3.3–11.4% per year which is even higher in patients with thyroid peroxidase antibodies. In Vangasena Samhita there is reference of Mahaajamoodadi taila Nasya in Galaganda which is having dravyas which are having all ushna veerya. Nasya is considered as a dwara to Shira and there are many theories about Nasya Drug reaching the Hypothalamus and Pituitary which are indirectly responsible for the functioning of the thyroid gland. The Hypothalamus links the nervous system to the endocrine system via pituitary gland. Hence Nasya may prove to be more fruitful therapy in management of hypothyroidism. Agni kumara Rasa is also having deepana, pachana and Agni uttejaka properties which may correct the Agni Mandhya. Hence Randomized Comparative Clinical Trial is proposed on oral administration of Agni Kumara Rasa and Nasya with Mahaajamoodadhya taila. No studies have so far been conducted on the role of Nasya in Subclinical Hypothyroidism and also on oral administration of Agni kumara rasa. Hence keeping in mind all the above parameters a study is proposed entitled " A Randomized Comparative Clinical Trial on Efficacy of Agni Kumar Ras and Maha Ajmodadi Taila Nasya in Subclinical Hypothyroidism With Special Reference to Agnimandhya.”
 Need for the study: 
Hypothyroidism is second most common metabolic disorder after diabetes mellitus. 10.9% of population are suffering from Hypothyroidism in India. Few clinical studies has been done in thyroid disorder with oral intervention but not even a single study is done on nasya therapy. Agni Kumara Rasa is a novel formulation found in Bhaisajya ratnawali 10/117-122 which has not been researched yet and is particularly mentioned in Agni mandhya chikitsa. Nasya in Hypothyroidism is a novel idea as there is no research done so far as Ayurveda postulates as “Nasa hi Shiraso dwaram” and the hypothalamus links the nervous system to the endocrine system via pituitary gland and there are chances of Nasya drug reaching this area via the olfactory pathway. Likewise Mahaajamoodadi taila is a specific oil mentioned in Galaganda in Vangasen samhita. Ayurveda has shown promising results in different metabolic disorders in various clinical studies on hypothyroidism. Agnimandhya can be best corrected through Ayurveda which may stimulates proper production of thyroxine hormone.
 
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