| CTRI Number |
CTRI/2024/10/075596 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Kanchanar Guggulu and Triphaladya Guggulu in Dhatwagnimandya(Hypothyroidis) |
|
Scientific Title of Study
|
Comparative clinical study of Kanchanar Guggulu and Triphaladya Guggulu in Dhatwagnimandya(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 Pooja Sharma |
| Designation |
Post graduate scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 13,Department of Kayachikitsa,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase1,Roorkee road,Haridwar,Uttrakhand,India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219708326 |
| Fax |
|
| Email |
pujusharma008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Cb Dhanraj |
| Designation |
Professor, Dept of Kayachikitsa |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 13,Department of Kayachikitsa,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase1,Roorkee
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7396174580 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cb Dhanraj |
| Designation |
Professor, Dept of Kayachikitsa |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 13,Department of Kayachikitsa,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase1,Roorkee
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7396174580 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Patanjali Yogpeeth phase1,Roorkee road,Haridwar,Uttrakhand,249405 |
|
|
Primary Sponsor
|
| Name |
Patnjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Patanjali Yogpeeth phase1,Roorkee road,Haridwar,Uttrakhand,249405 |
| Type of Sponsor |
Private 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 Cb Dhanraj |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD 13/14,Patanjali Ayurved Hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth, Phase1,Roorkee Road,Haridwar,Uttrakhand,India 249405
Hardwar
UTTARANCHAL |
7396174582
drcbdhanraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: AGNIVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladya guggulu, Reference: Dr Inderdev Tripathi (Comm.) and Dr Daya Shankar Tripathi (Comm.)(Revised ed. 2011) Yog ratnakar, Chaukhambha krishandas academy, Varanasi , India;Chapter Gandamala apchi chikitsa verse 57-58,P-587, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchanar guggulu, Reference: Kaviraj Govind Das Sen. Bhaisajva Ratnavali, edited by Mishra S, Galagandadi Roguadhikar: Chapter 44, Verse 63-68.Chaukhamba Surbharati Prakashan. Varanasi, (Reprint ed.).2016:Pg-806, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants fulfilling the signs and symptoms of hypothyroidism
2.TSH value greater than 4.5mIU/ml.- less then 30mIU/ml. It may or may not be associated with the decrease in serum T3 and T4 concentration.
3.Patients who are newly diagnosed or under Thyronorm [levothyroxine] medication
but presenting with the diagnostic criteria are included.
4.Patients willing to participate. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from other major systemic illnesses like Cardiac problems,
uncontrolled Diabetes, Tuberculosis, uncontrolled hypertension, and Malignancies.
2.Complicated cases of hypothyroidism like Thyrotoxicosis, Thyroid neoplasms.
3.Patients who have undergone any type of thyroid surgery.
4.Patients suffering from congenital Hypothyroidism and secondary Hypothyroidism.
5.Pregnancy and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective Criteria.
TSH value: greater than 4.5 mIU/ml and less than 30 mIU/ml
It may or may not be associated with the decrease in serum T3 and T4 concentration. |
0, 30áµ—Ê°,90áµ—Ê° Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Criteria.
1. Puffiness of face & eyelids
2. Dry & course skin
3. Cold intolerance
4. Hoarseness of voice
5. Hair Fall
6. Fatigue
7. Breathlessness
8. Oedema
9. Muscle Ache
10. Anorexia
11. Excessive Sleep
12. Constipation
13. Menstrual Abnormality (Females)
|
90áµ—Ê° Day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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 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
|
This study is a comparative clinical evaluation of Kanchanar Guggulu and Triphaladya Guggulu in Dhatwagnimandya (hypothyroidism). This will be conducted on 60 randomly selected patients from OPD of Kayachikitsa Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan , Haridwar. Patients will be divided into two groups- 30 patients will be given Kanchanar guggulu orally and 30 patients will be given Triphaladya guggulu orally. first follow up will be taken after 30 days of first visit and second follow up will be taken after 60th day of first follow up. Assesment will be done on the basis of subjective and objective parameter as discussed earlier .
|