| 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.
|
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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 |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda, Jaipur |
| Address |
Rajasthan, Jaipur, jorawar singh gate, 302002 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, National Institute of Ayurveda |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: MANDAGNIH/Â AGNISADA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. | | 2 | Comparator Arm | Drug | Classical | | (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: - |
|
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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). |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in TSH level. |
At baseline, 30th day and 60th day |
|
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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. |
|
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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. |