| CTRI Number |
CTRI/2024/08/072781 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of hypothyroidism with ayurvedic medicine punarnavadi leha & Aragvadhadi kashaya |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of
Punarnavadi Leha & Argvadhadi Kashaya In The Management Of Dhatvagnimandya W.S.R 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 |
BHANU PRIYA CHOUDHARY |
| Designation |
PhD Scholar |
| Affiliation |
Madan Mohan Malviya Govt Ayurveda College, Udaipur |
| Address |
Room no. 119 P.G. Department of Kayachikitsa Post Graduate Institute of Ayurveda Dr. Sarvapalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Madan Mohan Malviya Govt Ayurved College Radaji circle Ambamata Udaipur 310331
Udaipur
RAJASTHAN
342037
India |
| Phone |
9460670388 |
| Fax |
|
| Email |
drpriya.choudhary06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indumati sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Govt Ayurveda College, Udaipur |
| Address |
Vinayakam G 4 Krishna Complex
Hari das ji ki Magri Near Dr. Vishnu Mathur Udaipur
Madan Mohan Malviya Govt Ayurved College Radaji circle Ambamata Udaipur 310331
Udaipur
RAJASTHAN
310331
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHANU PRIYA CHOUDHARY |
| Designation |
PhD Scholar |
| Affiliation |
Madan Mohan Malviya Govt Ayurveda College, Udaipur |
| Address |
Room No. 119 P.G. Department of Kayachikitsa Post Graduate Institute of Ayurveda Dr. Sarvapalli Radhakrishnan Rajasthan Ayurved University jodhpur Rajasthan
Madan Mohan Malviya Govt Ayurved College Radaji circle Ambamata Udaipur 310331
Udaipur
RAJASTHAN
342037
India |
| Phone |
9460670388 |
| Fax |
|
| Email |
drpriya.choudhary06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda,Jodhpur, Rajasthan-342004 |
|
|
Primary Sponsor
|
| Name |
Bhanu Priya Choudhary |
| Address |
Post Graduate Institute Of Ayurveda.Dr. Sarvapalli Rajasthan Ayurved University, Jodhpur,Rajasthan ,Pincode 313001 |
| 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 Bhanu Priya Choudhary |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
Room No.119 ,post graduate department of Kayachikitsa,PGIA DSRRAU, Jodhpur
Jodhpur
RAJASTHAN |
9460670388
drpriya.choudhary06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Madan Mohan Malviya Government Ayurved College, Udaipur |
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: Punarnavadi leha, Reference: Chakradutta 39/43, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Aragvadhadi kashaya), Additional Information: Dose of Aragvadhadi kashaya will be 40 ml BID with Punarnavadi leha for 3 months duration | | 2 | Comparator Arm (Non Ayurveda) | | - | Levothyroxin | Synthethic form of the Thyroid hormone thyroxin | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi leha, Reference: Chakradutta 39/43, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Subjects having age between 18 to 60 years of either sex.
b)Newly diagnosed patients of TSH level 5-10 mlU/l.
c)Patients having any sign and symptom of Dhatwagnimandhya (Hypothyroidism) will be selected for the present study.
d)Patient willing to sign the consent form.
e)Patient is able to take the medicine properly and follow the Pathya -Apathya
f)Patient not taking any other medicine for this disease.
|
|
| ExclusionCriteria |
| Details |
a)Patients below 18 years and above 60 years of age.
b)Patients having TSH level more than 10 or less than 5.
c)Patients suffering from any other major acute/ systemic illness viz. Diabetes, HTN, liver disorders etc.
d)Pregnant women and lactating mothers.
e)Patients undergoing treatment for any other systemic illness.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any changes in the value of serum TSH. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of changes in specific symptoms of Dhatwagnimandhya (Hypothyroidism). |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/09/2024 |
| 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="0"
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
|
It is a randomized, prospective, open-label, interventional comparative clinical trial. The trial consists of three groups: one will receive Levothroxin, the second group will receive both punarnavadi leha and Aragvadhadi Kashaya and the third group will receive punarnavadi leha. Changes in subjective and objective parameters of Dhatvagnimandhya(Hypothyroidism) will be the endpoint of the study. |