| CTRI Number |
CTRI/2025/02/081143 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Dhanyaka Hima(Ayurvedic Coriander water prepration)And Regular fast paced walking in early stage of hypothyroidism. |
|
Scientific Title of Study
|
A randomized clinical trail to compare the efficacy of
Dhanyaka Hima And Brisk walking on serum TSH in Subclinical
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 Radha Mallaraddi |
| Designation |
PG Scholar |
| Affiliation |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan |
| Address |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan
Department of Swasthavritta
Room no 201
Jaipur
RAJASTHAN
302002
India |
| Phone |
8884656884 |
| Fax |
|
| Email |
radhanm7009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Associate professor |
| Affiliation |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan |
| Address |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan
Department of Swasthavritta
Room no 228
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Associate professor |
| Affiliation |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan |
| Address |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan
Department of Swasthavritta
Room no 228
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan
and Associated hospitals. |
|
|
Primary Sponsor
|
| Name |
College University |
| Address |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Radha Mallaraddi |
National institute of Ayurveda Madhav vilas hospital |
National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
8884656884
radhanm7009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee National institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanyaka hima, Reference: sharangadhar samhita Madyama khanda 2/7-8, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: morning before inatke of food | | 2 | Comparator Arm (Non Ayurveda) | | - | Brisk walking | Moderate intensity exercise
Brisk walking 40 minutes per day at the speed of approx.3 mile/hr.Rest period of two minute after 10 minutes of exercise. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic or asymptomatic subjects of either sex.
Serum T3 within Normal range
Serum T4 within normal range
Serum TSH -Between 5 and 15 mIU/L as an outpatient
Ability to provide consent. |
|
| ExclusionCriteria |
| Details |
Diagnosed case of Hypothyroidism.
Thyroidectomy.
Radiation therapy to neck area.
Radioactive iodine treatment,
Pregnant ladies.
Diagnosed patients suffering with any other chronic systemic disease example cardiac
problem, T.B. etc.
Secondary hypothyroidism, Tertiary hypothyroidism.
Patient taking Thyroxine or any other medications. |
|
|
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 serum level of TSH |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in BMI |
90days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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
|
Subclinical hypothyroidism is one of the major public health problems among both developed and developing countries.The treatment of Subclinical hypothyroidism is highly controversial. Overtreatment of Subclinical hypothyroidism can cause complications like nervousness, anxiety, tachyarrhythmias, angina pectoris and low bone mass, fractures and also shows symptoms of Thyrotoxicosis.Thus, a dietary component and lifestyle modifications which has slight side effects or free from side effects is a need and necessity for the management of Subclinical hypothyroidism. According to ayurvedic pathogenesis it occurs due to “Agnimandya” at the systemicand cellular level. Dhanyak hima and Brisk walking (laghu vyayama) having effect on Agni, are expected to prevent overt hypothyroidism and revert subclinical stage to euthyroid .Dhanyaka hima is being traditionally used in hypothyroidism condition by patients but no scientific study is available. |