| CTRI Number |
CTRI/2025/05/086140 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of vadavamukha churna and punarnavadya churna in dhatwagnimandya (hypothyroidism) |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of vadavamukha churna and punarnavadya churna in the management of dhatwagnimandya 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 |
Indu mundel |
| Designation |
Pg scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
6376716172 |
| Fax |
|
| Email |
indumundel6172@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu mundel |
| Designation |
Pg scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
6376716172 |
| Fax |
|
| Email |
indumundel6172@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indu mundel |
| Designation |
Pg scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
6376716172 |
| Fax |
|
| Email |
indumundel6172@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya government ayurved college udaipur rajasthan pin 313001 |
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya government ayurved college udaipur |
| Address |
Madan mohan malviya government ayurved college udaipur rajasthan 313001 |
| Type of Sponsor |
Government 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 ravi sharma |
Madan mohan malviya government ayurved college udaipur |
OPD no.1 kayachikitsa department Madan mohan malviya government ayurved college udaipur
Udaipur
RAJASTHAN |
9414419259
rspgkcj2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee mmm govt ayurved college ambamata udaipur |
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: SOPA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vadavamukha churna, Reference: Chakradatta agnimandya chikitsa 6/55, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NA | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnavadya churna, Reference: Yogaratnakar shothachikitsa/1,2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1.Patients willing for the trial.
2.Patients between the ages of 18 to 70 years of either sex.
3.Patients who are newly diagnosed of Hypothyroidism with increase TSH level.
4.The patient having clinical signs and symptoms of hypothyroidism.
5.TSH level more than 4.5 mlU/L |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1.Patients below the age of 18 years and above 70 years.
2.Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
3.Subjects having multi neoplasm and toxic goitre are excluded.
4.Patients who have undergone any type of thyroid surgery.
5.Pregnant and lactating women are excluded.
6.Patients suffering from Diabetic Mellitus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs and symptoms of hypothyroidism
2)Reduction in TSH level and increase in serum T3 and T4 level
3)Reduction in fatigue breathlessness weakness puffiness on face and weight gain |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thyroid profile- T3, T4 and TSH, ESR, Lipid profile, RBS, HB% level will be analysed. |
60 days |
|
|
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)
|
01/06/2025 |
| 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="0"
Months="11"
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
|
RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VADAVAMUKHA CHURNA AND PUNARNAVADYA CHURNA IN THE MANAGEMENT OF DHATWAGNIMANDYA W.S.R. TO HYPOTHYROIDISM
There will be two group in the study.
In Group A randomly selected and clinically diagnosed 30 patient of Dhatwagnimandya will be given Vadavamukha churna twice a day after meal.
In Group B randomly selected and clinically diagnosed 30 patient of Dhatwagnimandya will be given Punarnavadya churna twice a day after meal.
Both trial will be conduct for a period of 2 months.
Follow up of the case will be after 15 days that is four time during treatment.
Final assesment will be done after completion of two month course on the basis of subjective and laborateral assesment |