| CTRI Number |
CTRI/2024/12/078232 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF SHADDHARANA CHURNA WITH NIRGUNDI TAILA NASYA IN COMPARISON WITH THYROXINE IN THE MANAGEMENT OF HYPOTHYROIDISM. |
|
Scientific Title of Study
|
Open labelled comparative clinical Study of ayurveda treatement protocol with thyroxine in 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 Krutika Rajendra Hupare |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
Opd no 2,3,10 Kayachikista Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
8805774804 |
| Fax |
|
| Email |
krutikahupare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh I Swami |
| Designation |
Associate Professor Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurveda Mahavidylaya Solapur |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya,118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422957234 |
| Fax |
|
| Email |
santosh.swami@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krutika Rajendra Hupare |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurveda Mahavidylaya Solapur |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya,118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
8805774804 |
| Fax |
|
| Email |
krutikahupare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India |
|
|
Primary Sponsor
|
| Name |
Dr Krutika R Hupare |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krutika Rajendra Hupare |
Seth Sakharam Nemchand Jain Ayurveda Rugnalya |
Kayachikista OPD 3 2 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA |
8805774804
krutikahupare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Govindji Raoji Ayurveda Mahavidyalya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E03||Other hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Thyroxine | Tab Thyroxine 1.5 microgram per kilogram | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak, Procedure details: 2 Drops in each nostril empty stomach)
(1) Medicine Name: Nirgundi Taila, Reference: Chkradatta , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 3 Months | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shaddharana Churna, Reference: Bhaisaijya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed subject who are not on any medications and willing to take ayurvedic treatment
already diagnosed subject who are under thyroxin medicine and willing to take ayurvedic medications
subjects having serum TSH leval more than 4.5 micro international units per ml
|
|
| ExclusionCriteria |
| Details |
Congenital hypothyroidism or anatomical deformity related to thyroid gland.
Rapid progressive cases of Myxoedema.
Pregnancy and Lactation.
Individual with ischemic heart diseases, uncontrolled hypertension, myocardial infarction,cerebrovascular event, cardiac arrhythmias, active malignant disease, patient having PCOD or other hormonal disturbance excluded from study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To develop a protocol for Ayurvedic management of Hypothyroidism.
2.To assess effect on different clinical parameters such as Peripheral edema, Dry and coarse skin, Breathlessness, constipation, Lethargy, Hair loss, Weight gain in Hypothyroidism.
3.To assess the effect on changes in Thyroid profile.
|
90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To develop a protocol for Ayurvedic management of Hypothyroidism.
2.To assess effect on different clinical parameters such as Peripheral edema, Dry & coarse skin, Breathlessness, constipation, Lethargy, Hair loss, Weight gain in Hypothyroidism.
3.To assess the effect on changes in Thyroid profile.
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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="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
|
The Modern system of medicine is still exploring medicine for better and more effective management of hypothyroidism synthetic thyroid hormone derivatives may bring the value of thyroid stimulating hormone (TSH) and T4 to normal range, but the increased dosage and continuous medicine make the patient drug dependent till the end of life . The purpose of the study is to develop a protocol for the ayurvedic management of Hypothyroidism in terms of alleviation of sign and symptoms and to maintain serum concentration of T3, T4 without rise in serum TSH at normal level.Hypothyroidism is a commonly prevailing disorder in adult Indian population .It is estimated that about 42 million people suffer from thyroid disorder in India , of which hypothyroidism is most common with a prevalence of 5.4%4.Hence this topic is selected to study the trial drug Shaddharana Churna is a polyherbal formulation which act on rasa dushti ,kapha dusti. It causes Aampachan so that Jatharagnideepna and Dhatwagnideepna will be achieved In this way all the contents of Shaddharana churna helps to break the above Samprapti of Hypothyroidism by correcting dysfunction of Agni.In hypothyroidism the main pathology is present in thyroid gland, which is situated in the Urdhvajatru. Pratimarsha Nasya of Nirgundi Taila is choosen for Nasya Karma.
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