| CTRI Number |
CTRI/2025/02/080896 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Hinguvachadi vati orally in comparison with Kanchanara guggulu orally in the management of Hypothyroidism in adults of age group 18-60 years for a period of 45 days |
|
Scientific Title of Study
|
To study the efficacy of Hinguvachadi vati in comparison with Kanchanara guggulu in Hypothyroidism: A controlled randomized clinical study |
| 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 Ananya D R |
| Designation |
Post Graduate Scholar, Department of Kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital |
| Address |
Department of Kayachikitsa OPD No 1, 2, 3, 18, 27
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital
Anchepalya Kumbalagodu post
Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
09538237102 |
| Fax |
|
| Email |
ananyabellur98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasa S |
| Designation |
Professor and Head of the Department, Department of Kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital |
| Address |
OPD Number 2
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital
Anchepalya Kumbalagodu post
Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
09448211053 |
| Fax |
|
| Email |
ssomayaji78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya D R |
| Designation |
Post Graduate Scholar Department of Kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital |
| Address |
Department of KAyachikitsa OPD No 1, 2, 3, 18, 27
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital
Anchepalya Kumbalagodu post
Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
09538237102 |
| Fax |
|
| Email |
ananyabellur98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa OPD No 1, 2, 3, 18, 27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya Kumbalagodu post Bengaluru 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Ananya D R |
| Address |
Department of Kayachikitsa OPD No 1, 2, 3, 18, 27 Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital
Anchepalya Kumbalagodu post
Bengaluru 560074, Karnataka, India |
| 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 Ananya D R |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
Department of Kayachikitsa OPD No 1, 2, 3, 18, 27 Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital
Anchepalya Kumbalagodu post
Bengaluru 560074, Karnataka, India
Bangalore
KARNATAKA |
09538237102
ananyabellur98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hinguvachadi vati , Reference: ASTANGA HRIDAYA GULMA CHIKITSA 14th CHAPTER 31 to 33 SHLOKA (14/31-33) , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchanara guggulu , Reference: BHAISHAJYA RATNAVALI GALAGANDA ROGADHIKARA 44th CHAPTER 64 to 69 SHLOKA (44/64-69), Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria between the age of 18 years to 60 years with irrespective sex, caste and religion.
2. Thyroid stimulating hormone (TSH) level more than 4.25mIL/ml (preferably upto 60mIU/ml)
3. Fresh cases and patients on medication of hypothyroidism maintaining the manufacturer and batch compulsorily with persisting signs and symptoms and altered quality of life.
|
|
| ExclusionCriteria |
| Details |
1. Patients with age below 18years and above 60 years.
2. If serum TSH level more than 60uIL/ml.
3. Patients who have under gone any type of thyroid surgery.
4. Patients with congenital and secondary hypothyroidism.
5. Patients suffering from systemic diseases like Cardiac disorders, uncontrolled Diabetes, uncontrolled Hypertension, Carcinoma and Sepsis.
6. Drug induced hypothyroidism, Myxedema coma, neoplasia and toxic goiter.
7. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvements noticed in reduction of signs and symptoms in patients diagnosed with Hypothyroidism with Zulewski’s scale. |
0th day (baseline), 45th day, 60th day and 75th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements noticed in the thyroid profile levels along with Quality of life. |
0th day (baseline), 45th day, 60th day and 75th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A controlled clinical study on the efficacy of Hinguvachadi vati in comaparison with Kanchanara guggulu in the management of Hypothyroidism in adults of age group 18-60 years for a period of 45 days. During this study period 30 subjects diagnosed with Hypothyroidism will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group)15 subjects in each group respectively. Group A (Trial drug/Intervention group) includes 15 subjects qualifying inclusion criteria of the current study will be administered Hinguvachadi vati orally in the dose of 2g TID followed by ushnajala pana for 45 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 45th day and after trial on 60th day and 75th day. Group B (Control Drug/Comparator Group) includes 15 subjects qualifying inclusion criteria of the current study will be administered Kanchanara guggulu 1g TID followed by ushnajala pana for 45 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 45th day and after trial on 60th day and 75th day. The primary outcome measure will be improvements noticed in reduction of signs and symptoms in patients diagnosed with Hypothyroidism with Zulewski’s scale after 45 days. The secondary outcome measure will be improvement noticed in the thyroid profile levels along with quality of life through ThyPro39 scale questionnaire after 45 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment. |