| CTRI Number |
CTRI/2019/05/019409 [Registered on: 29/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Thyroid |
|
Scientific Title of Study
|
Clinical evaluation of the effect of Kanchnar guggulu Baheda churna & Panchakola churna in the management of dhatwagni mandya (Hypothyroidism) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NO |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Mourya |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital
Girls Hostel Patanjali phase 1 Patanjali yogpeeth haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8839885427 |
| Fax |
|
| Email |
pmrubi.mourya8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital
Vanprasth Aashram, Patanjali phase 2
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital
Vanprasth Aashram, Patanjali phase 2 Patanjali yogpeeth haridwar
Uttarkashi
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Priyanka Mourya |
Girls Hostel, Patanjali Phase 1 Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Mourya |
Patanjali Ayurveda Hospital |
OPD no. 12 Department of Kayachikitsa
Hardwar
UTTARANCHAL |
8839885427
pmrubi.mourya8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2017-18/11 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kanchnar guggulu. Baheda churna and Panchkola churna |
1. Kanchnar guggulu- 2 tab BD after meals with lukewarm water
2. Baheda churna- 3 gm BD After meals with lukewarm water
3. Panchkola churna- 1gm BD after meals with lukewarm water
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Serum T3, T4 and TSH levels which indicates Hypothyroidism.
2. Patients between the age group of 18-60 years of either sex.
3. Patient irrespective of sex, religion, occupation and chronicity will be selected.
4. TSH value : >5.0 mIU/ml - <20 mIU/ml.It may or may not be associated with the decrease in serum T3 and T4 concentration.
|
|
| ExclusionCriteria |
| Details |
1. Patients associated with any other systemic disorders like cardiac problem, carcinoma will be excluded.
2. Thyroid abnormality in pregnancy will be excluded.
3. Patients with complaints of Thyroid tumour will be excluded.
4. Post-operative cases of thyroid abnormality will be excluded.
5. Patients aged <18 years or >60 years will be excluded
6. Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
7. Hypothyroidism with co-morbid condition
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Serum Tri-iodothyronine(T3)
2. Serum Tetra-idothyronine (T4)
3. Serum Thyroid stimulating hormone (TSH)
|
Before inervention and Ist follow-up of 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Serum Tri-iodothyronine(T3)
2. Serum Tetra-idothyronine (T4)
3. Serum Thyroid stimulating hormone (TSH)
|
After inervention at 2 months (completion of treatment) |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/06/2019 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial, we are selecting patients of Hypothyroidism in which we will intervene in two groups (25 patients in each group). In one group, we will intervene our ayurvedic preparation (Kanchnar
guggulu, Baheda
churna and Panchkola churna) . Assessment should be done on the basis of investigations done pre-treatment, during follow up and post treatment as discussed earlier. |