| CTRI Number |
CTRI/2022/09/045491 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Drug With and Without Yoga In Cases Of Hypothyroidism. |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Gomutra Bhavit Jalkumbhi Bhasma And KPG Vati With And Without Ujjayi Pranayama In Cases Of Hypothyroidism. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti |
| Designation |
Research Scholar |
| Affiliation |
State Ayurvedic College and Hospital |
| Address |
Post Graduate Department of kayachikitsa, State Ayurvedic college and Hospital, Lucknow 226003
S.A.C and H. Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7398908358 |
| Fax |
|
| Email |
jyotikharya5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anant krishna |
| Designation |
Lecturer , S.A.C.and H. Lucknow |
| Affiliation |
State Ayurvedic College and Hospital |
| Address |
State Ayurvedic college and Hospital, Lucknow 226003
State Ayurvedic college and Hospital, Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9452274856 |
| Fax |
|
| Email |
anant10patel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti |
| Designation |
Research Scholar |
| Affiliation |
State Ayurvedic College and Hospital |
| Address |
Post Graduate Department of kayachikitsa, State Ayurvedic college and Hospital, Lucknow 226003
S.A.C.and H,Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7398908358 |
| Fax |
|
| Email |
jyotikharya5@gmail.com |
|
|
Source of Monetary or Material Support
|
| State ayurvedic college and hospital Tulsidas marg Lucknow 226003 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and hospital,Lucknow 226003 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr jyoti |
State Ayurvedic College and Hospital Lucknow |
Departmentof Kayachikitsa opd no 9,and pain management and thyroid care Lucknow U.P. 226003
Lucknow
UTTAR PRADESH |
7398908358
jyotikharya5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gomutra Bhavit Jalkumbhi Bhasma, Reference: Chakradatta, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Nil | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: KPG Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Nil | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gomutra Bhavit Jalkumbhi Bhasma, Reference: Chakradatta, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Nil | | 4 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: KPG Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Nil | | 5 | Intervention Arm | Lifestyle | - | - | Dinacarya: Morning (6-8 am) at 15 min, Ritucarya: Nil, Acara Rasayana:Nil, Other:Nil, Pathya/Apathya:no, Pathya:, Apathya: |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are freshly diagnosed or mild cases of Hypothyroidism with increased TSH level(TSH level between > 4.5-12.5 microIU/ml
2. Patients who are ready to switch over to Ayurvedic medicine and have signed the consent form.
3. 4 out of 6 major symptoms and minor symptoms may or may not be signed the consent form.
4. Patients with hypothyroidism who are interested in involving themselves in pranayama practice with drugs treatment.
|
|
| ExclusionCriteria |
| Details |
1.TSH level above 12.5 microIU/ml.
2. Patients who have under gone any type of thyroid surgery and recent abdominal or spinal surgery.
3. patients whose symptoms are worsely aggravated after leaving the modern drug Levo-thyroxine( in the washout period).
4. Hyperthyroidism, Neoplasia, toxic goiter are excluded..
5. Patients suffering from congenital hypothyroidism.
6 Obese female with pregnancy or lactation and children. |
|
|
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 |
Clinical outcome assessment among the people registered under the study will be done through -
Increased level of TSH above (4.5microIU/ml),weight gain, oedema, Hoarseness of voice ,constipation,Generalized pain etc
all signs symptoms are graded 0,1,2,3 on the basis of intensity confirmed by clinical examination before trial.The clinical improvement during and after trial will also be correlated and assess with previous grading. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life improvement. |
90 days |
|
|
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)
|
15/09/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
AIM & OBJECTIVES-
a.
To assess the probable mode of action of ayurvedic drug
along with Ujjayi Pranayama combination in the management of the
Hypothyroidism.
b.
To
assess the effectiveness of trial drug in the cases of Hypothyroidism.
c.
To
normalize the levels of TSH in the mild cases.
d.
To assess
the effect of the trial drug on resistant cases of levothyroxine.
e.
To
gradually replace the hormone (levothyroxine) with the trial drug.
f.
To find
out an easily available, economical, safe and effective remedy for the management
of Hypothyroidism.
TYPE OF STUDY-
Phase-2,
Randomized and Rational Study.
PERIOD OF STUDY-
Total duration of
clinical Trial is 90 days with fortnightly follow up for symptoms and monthly
follow up for Thyroid Function Test.
FOLLOW UP PERIOD-
15 days after treatment.
SELECTION OF CASES
For the
purpose of clinical trial, the patients of Hypothyroidism will be selected
randomly from OPD and IPD of State Ayurvedic College & Hospital, Lucknow
and referred cases of other hospital.
A
careful history, physical examination & necessary investigation will be
performed as per proforma prepared for the present trial.
SAMPLE SIZE-
Minimum of 40 patients of Hypothyroidism from OPD/ IPD of State Ayurvedic
College & Hospital, Lucknow will be selected and treated with the trial
drug. Patients who are using the allopathic drug Levo-thyroxine will be given
the trial drug after washout period of at least 15 days for the allopathic
drug. There will be 2 groups :-
Group A – Patients will be given capsule of Gomutra bhavit Jalkumbhi Bhasma 500
mg BD and KPG Vati 250 mg 2BD empty stomach along with Ujjayi Pranayama at 15
min at morning (6-8 am) for 3 months.
Group B – Patients will be given capsule of
500 mg BD Gomutra bhavit Jalkumbhi Bhasma and KPG Vati 250 mg 2BD empty stomach
for 3 months.
Minimum 40 Patients
with approximately 10% drop out.
|