FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
Close