| CTRI Number |
CTRI/2020/10/028181 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Polyherbal formulation in management of hypothyroidism. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL ON EFFECTIVENESS OF POLY HERBAL FORMULATION 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 Phartale Vaibhav Dattatray |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
ground floor,cabin no 2 ,ssam & h nashik
kamal nagar,Hirawadi,panchavati,Nashik
Nashik
MAHARASHTRA
422009
India |
| Phone |
9766477111 |
| Fax |
0253-2621638 |
| Email |
vdphartale2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Phartale Vaibhav Dattatray |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
ground floor,second no opd, SSAM &h Nashik
First floor,KAyachikitsa department, SSAM &h Nashikkamal nagar,Hirawadi,panchavati,Nashik
Nashik
MAHARASHTRA
422009
India |
| Phone |
9766477111 |
| Fax |
0253-2621638 |
| Email |
vdphartale2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Babel Sadhana Prafulkumar |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
ground floor,second no opd, SSAM &h Nashik
First floor,Kayachikitsa department, SSAM &h Nashik nagar,Hirawadi,panchavati,Nashik
Nashik
MAHARASHTRA
422009
India |
| Phone |
9766477111 |
| Fax |
0253-2621638 |
| Email |
sadhana.babel81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashruungi Ayurved mahavidyalaya and hospital ,Nashik |
|
|
Primary Sponsor
|
| Name |
OPD and IPD of Shree Saptashrungi Ayurved Hospital |
| Address |
kamal nagar , hirawadi,panchavati,Nashik |
| Type of Sponsor |
Private 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 Phartale Vaibhav Dattatray |
Shree Saptashrungi Ayurved mahavidyalaya and hospital |
kayachikitsa department,first floor ,room no 3, kamal nagar hirawadi panchavati nashik
Nashik
MAHARASHTRA |
8605431111
02532621638
vdphartale2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E03||Other hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
New Poly Herbal Formulation |
Poly Herbal Formulation in Tablet form (5oo mg tab) for 90 days will be administered 2 gm per day. Divided dose of 2 tablets twice a day orally two times after food with Ushnodaka for 90 days. |
| Comparator Agent |
Tab Thyroxine |
Control Group will be given Tab Thyroxine According to dose calculations as per TSH values in patients for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed cases of Hypothyroidism on the basis of S. TSH, T3 and T4 levels.
Patients having at least 3 clinical features of Hypothyroidism among
Following a )Tiredness/Somnolence
b) Unexplained weight gain
c) Depression
d) Cold intolerance
e) Hoarse voice
f) Goiter
g) Oedema or A puffy face
h) Constipation
i) Dry skin
j) Muscle aches, tenderness and stiffness
k) Menstrual irregularity
l) Hair loss |
|
| ExclusionCriteria |
| Details |
Patients with -
1. Patient undergoing any known Hormonal Therapy even for thyroid also.
2. Ischemic Heart Diseases, Uncontrolled Hypertension, Uncontrolled Diabetes Mellitus, Myocardial Infarction, Cerebrovascular event, Cardiac Arrhythmias, Pregnancy, Lactating mothers, Active Malignant Disease, Chronicity more than 10 years.
3. Patient age below 18 year and above 60 year of either sex. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Whether New Ploy Herbal Formulation containing Hamsapadi, Jalkkumbhikshar, Kanchanar,Guduchi,Pimpali, Shigru,Kirattikta is effective in reducing TSH value and signs & symptoms of Hypothyroidism . |
Day 0 then 15th then 30th then 60st and 90th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Purpose of the study Hypothyroidism is posing a major challenge both in developing as well as developed world. It is estimated that about 42 million people suffer from thyroid disorders in India, out of which Hypothyroidism is most common with prevalence of 5.4% 3. Women are affected approximately six times more frequently than men.4 With the changing life style of 21st century Hypothyroidism is considered as one of the commonest endocrinal disorder. Presently the available treatment is oral supplementation of artificially synthesized Levothyroxine with main goal to normalize TSH but not effective symptomatically 5. It has many adverse effects. It requires a systemic and radical therapy for which Ayurveda may provide a ray of hope through Shamana Chikitsa So there is a need of time to have safe and effective Ayurvedic management. Hence an attempt is made to offer effective Poly Herbal formulation in management of hypothyroidism. AIMS AND OBJECTIVES: To evaluate the clinical efficacy of New Poly herbal formulation in the management of Hypothyroidism. PRIMARY OBJECTIVE: 1. To study changes in S.TSH level. SECONDARY OBJECTIVES: 1. To study improvement in signs & symptoms of Hypothyroidism, 2. To study Hypothyroidism in details with its pathophysiology according to modern and ayuerveda sciences. 3. To study the drugs used in New polyherbal formulation in detail.
HYPOTHESIS: NULL HYPOTHESIS (H0): New Poly herbal formulation is not effective in management of hypothyroidism. ALTERNATIVE HYPOTHESIS (H1): New Poly herbal formulation is effective in management of hypothyroidism.
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