| CTRI Number |
CTRI/2024/08/072053 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of triphala yoga in Hypothyroidism |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Study the Adjuvant Effect of Triphala Yoga
in Galaganda with special reference to 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 Gauri Prakash Borude |
| Designation |
Pg scholer |
| Affiliation |
SMBT Ayurveda College and hospital |
| Address |
Department of Kaychikitsa SMBT Ayurveda College and hospital,Nandi hills,Dhamangaon.
Tal-Iagatpuri
Dist-Nashik
Maharashtra
India
Post code:-422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9130494132 |
| Fax |
|
| Email |
gauriborude777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayuri S Patil |
| Designation |
Associate professor |
| Affiliation |
SMBT Ayurveda College and hospital |
| Address |
Department of Kaychikitsa
SMBT Ayurveda College and hospital ,Dhamangaon ,Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8668549430 |
| Fax |
|
| Email |
dr.mayuripawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayuri S Patil |
| Designation |
Associate professor |
| Affiliation |
SMBT Ayurveda College and hospital |
| Address |
Department of Kaychikitsa
SMBT Ayurveda College and hospital ,Dhamangaon ,Nashik
MAHARASHTRA
422403
India |
| Phone |
8668549430 |
| Fax |
|
| Email |
dr.mayuripawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaychikitsa
SMBT Ayurveda College and hospital, nandi hills, Dhamangaon, Nashik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Gauri Prakash Borude |
| Address |
SMBT Ayurveda College and hospital Nandi hills, Dhamangaon, Nashik 422403 |
| 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 Gauri Prakash Borude |
SMBT Ayurveda College and hospital |
OPD no 10
Department of Kaychikitsa
SMBT Ayurveda College and hospital, Nandi hills, Dhamangaon,Nashik422403
Nashik
MAHARASHTRA |
9130494132
gauriborude777@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT AYURVEDA COLLEGE AND HOSPITAL,NANDI HILLS,DHAMANGAON 422403 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala yoga, Reference: Gadnigrah , Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -since it is adjuvant effect study trial group will receive tab levothyroxine and triphala yoga simultaneously | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab levothyroxine | Drug tab Levothyroxine OD
Dose 1 mcg/kg
Route of administration oral
Time morning |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients positive for Zulewski’s clinical score for hypothyroidism.
2)Patient fulfilling the laboratory diagnosis of hypothyroidism on the basis of serum TSH, T3 and T4 levels.
3)Patient’s serum TSH level between 4.5 μIU/ml to 20 μIU/ml
4)Total serum T3 and T4 level less than normal value.
5)Patients having uncontrolled TSH level in spite adequate doses of
Levothyroxine.(dose between 25mcg/kg and 100mcg/kg)
6)Patients having signs and symptoms of Hypothyroidism |
|
| ExclusionCriteria |
| Details |
1)Patients with ischemic heart disease, uncontrolled hypertension, myocardial
infarction, cerebrovascular event, cardiac arrhythmias, pregnancy and
active malignant disease were excluded from the study.
2)Patients with altered thyroid hormone levels due to other
conditions.
3) Patients having TSH level greater than 19.9mIU/L.
4)Patients suffering from diseases like HIV, TB, Encephalopathy, Goiter, Other
endocrine disorders and other autoimmune disorders.lactating and pregnant women.
5)Patients taking dose of levothyroxine more than100mcg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the adjuvant effect of Triphaladi Yoga on
subjective and objective parameters in the cases of Galganda with special reference to hypothyroidism
Subjective criteria is
Zuleinskis clinical score
Objective criteria is
Reduction in TSH profile |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/08/2024 |
| 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) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Thyroid disorders are among commonest endocrine disorders in worldwide.The thyroid axis is involved in the regulation of cellular metabolism in virtually all nucleated cells.so the disorders of thyroid function have diverse manifestations.hypothyroidism is common presentation of thyroid function disorder.The overall prevalence of hypothyroidism is 10.95. The present study aims to assess the adjuvant effect of Triphaladi yoga on subjective and objective parameters in the cases of Galaganda w.s.r. to hypothyroidism. This study is done to see the adjuvant effect of Triphaladi yoga internally in management of Galaganda with special reference to hypothyroidism in 90 days of treatment duration of total 60 patients.the patients within the age roup of 18 to 60 years who fullfilled the clinical diagnostic criteria for hypothyroidism and had symptoms of galganda as mentioned in classics were selected irrespective of sex socio economic status and community,written consent from patient were taken prior to the study .computerized generated sampling technique for randomization was used.toral 64 patients will be selected and devided into group A and group B of which Group a trial group and G roup b control group.4 patients had withdrwan from the trial .triphla yoga in trial group A and tab levothyroxine in group b is was administrated .observations were made on day 0 day 30 th, day 60 th,day 90 th,and day 120 th.there was reduction in syptoms of galganda .statistical data calculation is pending .discussion will be drawn after statistical analysis.summary will be drwan and whole thesis work will be summarized .conclusion will be drwan strictly .on the basis of statistical analysis will be unbiased. |