| CTRI Number |
CTRI/2023/09/057846 [Registered on: 19/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment for hypothyroidism with herbal medicine |
|
Scientific Title of Study
|
An Open Labelled Comparative RCT Study On Assessment Of Combined Efficacy Of Gomutra Mandooram,Ayugma Aragwadadhi Kashaya Basti and Guda Haritaki Rasayana In the Management Of Hypothyroidism(Kaphavataja Vikara) |
| 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 Jaishree |
| Designation |
kayachikitsa post graduate scholar |
| Affiliation |
Taranath goverment ayurvedic medical college and hospital,bellary.583101 |
| Address |
Department of PG Studies in Kayachikitsa Room Number 1 Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary
583101
Bellary
Karnataka
583101
India
Bellary
KARNATAKA
583101
India |
| Phone |
8050047304 |
| Fax |
|
| Email |
jaishreebiradar18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRamling S Hugar |
| Designation |
MD(ayu)Assistant professor |
| Affiliation |
Taranath goverment ayurvedic medical college and hospital,bellary.583101 |
| Address |
Department of PG Studies in Kayachikitsa Room Number 1 Taranath Government Ayurvedic Medical College and Hospital Dr. Rajkumar Road Bellary
583101
Bellary
Karnataka
583101
India
Bellary
KARNATAKA
583101
India |
| Phone |
8971311520 |
| Fax |
|
| Email |
ramshugar22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaishree |
| Designation |
Kayachikitsa Post Graduate Scholar |
| Affiliation |
Taranath Government Ayurvedic Medical College and Hospital,Bellary.583101 |
| Address |
Department Of PG Studies in Kayachikitsa Room Number 1 Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary
583101
Bellary
Karnataka
583101
India
Bellary
KARNATAKA
583101
India |
| Phone |
8050047304 |
| Fax |
|
| Email |
jaishreebiradar18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Taranath Government Ayurvedic Medical College and Hospital Dr. Rajkumar Road Bellary
583101
Bellary
Karnataka
583101
India |
|
|
Primary Sponsor
|
| Name |
Taranath Goverment Gyurvedic Medical college and hospital bellary |
| Address |
Department of PG Studies in Kayachikitsa Room Number 1 Taranath Government Ayurvedic Medical College and Hospital Dr. Rajkumar Road Bellary
583101
Bellary
Karnataka
583101
India |
| Type of Sponsor |
Government medical college |
|
|
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 Jaishree |
Taranath goverment ayurvedic medical college and hospital bellary 583101 |
Department of PG Studies in Kayachikitsa Room Number 1 Taranath Government Ayurvedic Medical College and Hospital Dr. Rajkumar Road Bellary
583101
Bellary
Karnataka
583101
India
Bellary
KARNATAKA |
8050047304
jaishreebiradar18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath Government Ayurvedic Medical College Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: GALAGANDAH, (2) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: GALAGANDAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Asthanga Hradaya, Procedure details: Poorvakarma : Sthanika Patra Pinda Sweda
Pradhana karma : Aragwadadhi Kashaya-250-300ml
prepared basti dravya will be put into a clean sterile polythene bag then disposable basti netra will be tied using a thread. Then nozzle will be closed after the complete evacuation of the air. After sthanika patrapindasweda patient should lie down in left lateral posture, folding the right knee & extending left. After lubrication nozzle will be administered slowly, then vasti dravya will be pushed gentl)
(1) Medicine Name: Gomutra mandooram, Reference: Yogaratnakara Shotharoadhikara, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 63 Days(2) Medicine Name: Guda Haritaki Rasayana, Reference: Yogaratnakara shotharogadhikara, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Duration: 21 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are diagnosed with Hypothyroidism with or without medicine and with or without washout period.
TSH value more than 5mIU/ml
Subjects between the age of 18 to 60 years.
Subjects who are fit for Basti Karma.
Those subjects who are ready to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of cardiac disease, congenital anomalies.
Patients suffering from congenital Hypothyroidism and carcinoma of the thyroid gland, Thyroid nodules,goiter, Thyroiditis, myxedema, and its complication, thyrotoxicosis, post-operative hypothyroidism, hypothyroidism post radio iodine therapy, hypothyroidism in pregnancy,lactating woman.
Also the subjects suffering from severe systemic disorders which interferes with course of intervention will be excluded.
Those who are not fit for Basti karma |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
correction of TSH level
qualitive of life improvements |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correction of TSH level
Imrovement in QOL |
8 weeks |
Improvement of Hb%
Improvement of subjective parameters |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/09/2023 |
| 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="2"
Days="3" |
|
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
|
 summary of the study
Hypothyroidism refers to any state that results in the deficiency of thyroid hormone, including hypothalamic or pituitary disease and generalized tissue resistance and autoimmunity to thyroid.it affects approximately one in 10 adults in the study population.female gender and older age were found to have significant association with hypothyroidism Basti helps to convert dysbiotic state of intestinal flora in symbiotic stae so for that region considered basti in this study for intervention.basti acts at enteric nervous system and influences cellular level and stimulate HPT axis by virtue of thyroid gut connection by gut microbiota modulation.gomutra mandooram contains mandoora triphala, trikatu,chavya which are kaphavatajara,does amapachana,agnideepana and shothahara.guda haritaki is rasayana, promotes anabolism of healthy dhatu,does deepana ,doshanulimana so study is undertaken for assessment of combined efficacy of gomutra mandooram, ayugma aragwadhadi kashaya basti and guda haritaki rasayana in the management of Hypothyroidism
Objective of the study - To evaluate the combined efficacy of gomutra mandooram, ayugma aragwadhadi kashaya basti and guda haritaki rasayana in the management of Hypothyroidism
- To assess the effect of modern ongoing treatment in the management of Hypothyroidism
- To compare the combined effect of gomutra mandooram, ayugma aragwadhadi kashaya basti and guda haritaki rasayana over modern ongoing treatment for hypothyroidism
Study design
Study type: randomised clinical trial, comparative prospective Estimated enrollment -80 Interventional model-2 group assignment Allocation -Randomized Study duration -63 days Masking-open Follow up after-15 days
Assessment criteria - High TSH level(as per report/evaluator)
- Symptoms like kesha chyuthi,klama,angamarda,aniyata arthava etc
- Correct of thyroid profile
|