CTRI Number |
CTRI/2017/10/010066 [Registered on: 12/10/2017] Trial Registered Retrospectively |
Last Modified On: |
26/09/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A Clinical study ayurvedic medicines Chitrakadi Vati and Avipathi Churnam in the management of Hypothyroidism |
Scientific Title of Study
|
An open label single arm clinical study on the combined effectiveness of Chitrakadi Vati and Avipathi Churnam in the management 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 ANOOP A S |
Designation |
Post Graduate Scholar Dept Of Kayachikitsa |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
PG Studies Department of Kayachikitsa
Hassan KARNATAKA 573201 India |
Phone |
08172256460 |
Fax |
|
Email |
asanoopas@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Diwakar Papurao Joshi |
Designation |
Professor |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Dept Of Kayachikitsa
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Hassan KARNATAKA 573201 India |
Phone |
08172256460 |
Fax |
|
Email |
joshidpayu@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Diwakar Papurao Joshi |
Designation |
Professor |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Dept Of Kayachikitsa
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Hassan KARNATAKA 573201 India |
Phone |
08172256460 |
Fax |
|
Email |
joshidpayu@gmail.com |
|
Source of Monetary or Material Support
|
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
B M road Thanniruhalla Hassan
Karnataka
573201
|
|
Primary Sponsor
|
Name |
Dr Anoop A S |
Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 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 ANOOP A S |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
P.G studies in Department of Kayachikitsa Hassan KARNATAKA |
9731298845
asanoopas@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Hypothyroidism, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Chitrakadi Vati
Avipathi Churnam
|
Chitrakadi Vati
Chitrakadi Vati will be given 1 tablet (250 mg) twice daily with lukewarm water before food for 84 days
Avipathi Churnam
Avipathi Churnam will be given 12 gms early morning in empty stomach with honey once in a month for 3 consecutive months with exact 1 month gap |
Comparator Agent |
None |
None |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Diagnosis will be made on the basis of TSH value more than 15-20 mU/l which may or may not be associated with decrease in T3 and T4 concentration and also with the signs and symptoms of Hypothyroidism one or multiplicity of these viz
1.tiredness,
2.dryness of skin,
3.feeling cold
4.hair loss,
5.constipation,
6.Weight gain with poor appetite
7.Hoarseness of voice,
8.muscle ache or stiffness,
9.menstrual disturbances,
10.Bradycardia
11.periorbital puffiness.
Inclusion criteria include
1.Patients of age between 18 to 60 years of either gender
2.Patients already diagnosed as hypothyroidism with or without medication,
3.Patients with Primary hypothyroidism,
4.Patients with subclinical hypothyroidism,
5.Patients who are ready to sign the informed consent form
|
|
ExclusionCriteria |
Details |
Exclusion criteria are as follows
1.Patients who have undergone any type of thyroid surgery,
2.Patients suffering from systemic diseases like Ischemic Heart Disease, Diabetes mellitus, carcinomas,
3.Patients suffering from congenital hypothyroidism,
4.Pregnancy and lactation,
5.Rapid progressive case of myxedema,
6.Hypothyroidism due to drug therapy (e.g. Amiodarone, Lithium, Interferon)
7.Hypothyroidism due to infiltrative diseases like Sarcoidosis,Scleroderma and Haemochromatosis
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Assessment of subjective parameters will be done on 1st day,10th day, 41st day, 71st day and 90th day with the help of a suitable clinical scoring of hypothyroidism – BILLEWICZ SCORE
The parameters in BILLEWICZ SCORE are the following signs and symptoms:
Symptoms are Diminished sweating,Dry skin,Cold intolerance,Weight increase,
Constipation, Hoarseness of voice and
Deafness
Signs are Slow movements, Coarse skin,
Cold skin, Periorbital puffiness, Pulse rate and Ankle jerk
|
90 DAYS |
|
Secondary Outcome
|
Outcome |
TimePoints |
Serum T3, T4, TSH |
90 days |
|
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 |
Date of First Enrollment (India)
|
27/02/2017 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Current clinical study is single arm clinical trial to
evaluate the combined effectiveness of Chitrakadi Vati and Avipathi Churnam-two
Ayurveda formulations in the management of hypothyroidism.In the present study, an open label single arm
clinical trial at IPD basis will be done with pre and post-test design for the
included 30 patients.Here Chitrakadi Vati 250 mg twice daily in the morning and
night will be administered before food with ushnodaka as anupana for the first
8 days.On the 9th day Koshta Shuddhi (administration of laxative
medicine for internal purification) as a part of sroto
sodhana will be done with Avipathi Churnam in a dose of 10gms with Honey in
early morning in empty stomach.Samsarjana karma (wholesome diet) will be
observerd for the next day.The patient will be discharged with Chitrakadi vati
for the next 30 days.After 30 days,the second course of Koshta Shuddhi
(administration of laxative medicine for internal purification) will be
done with Avipathi churnam in the same dose i.e on the 40th day.On
the next day samsarjana karma (wholesome diet) will be observed.The patient
will be discharged with Chitrakadi vati to be taken in the same dose as before
for 30 days.After 30 days i.e on the 70th day last course of Koshta
Shuddhi will be done with Avipathi Churnam in the same dose as before.On the
next day samsarjana karma will be observed and the patient will be discharged
with Chitrakadi vati for the next 20 days i.e till the 90th
day.Hence the entire treatment will be completed in 90 days.
The
patient will be assessed on the 1st day and 90th day with
investigations like Thyroid profile and BMI. The signs and symptoms will be
assessed using Billewicz scoring system on the 1st day, 10th
day, 41st day, 71st day and on the 90th day.
Assessment would be done based on subjective and objective parameters and would
also be monitored for Adverse Drug Reactions or Adverse Drug Effects or other
concurrent illness
|