| CTRI Number |
CTRI/2017/09/009868 [Registered on: 20/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of a Thyroid (Hypothyroidism) with gomutra haritaki tablet |
|
Scientific Title of Study
|
Clinical study in management of Primary Hypothyroidism with Gomutra Haritaki with special reference to Kaphaja Pandu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu Sheoran |
| Designation |
Post Graduate (Scholar) |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
Parul Institute of Ayurved, Parul University, PO-Limda, Tal.Waghodia, Distt. Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9726279864 |
| Fax |
|
| Email |
ritusheoran0609@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N J Trivedi |
| Designation |
Professor and Head of Department |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved, Parul University, PO-Limda, Tal.Waghodia, Distt. Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824846993 |
| Fax |
|
| Email |
nj.trivedi30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N J Trivedi |
| Designation |
Professor and Head of Department |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved, Parul University, PO-Limda, Tal.Waghodia, Distt. Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824846993 |
| Fax |
|
| Email |
nj.trivedi30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved & Hospital, Parul University, PO- Limda, Tal- Waghodia, Distt. Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Ritu Sheoran |
| Address |
Parul Medical Girls Hostel,
Parul Institute of Ayurved,Parul University, PO- Limda, Tal- Waghodia, Distt. Vadodara, Gujarat |
| 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 Ritu Sheoran |
Parul Institute of Ayurved |
Kayachikitsa Department,OPD No-106,Parul Ayurved Hospital
Vadodara
GUJARAT |
9726279864
ritusheoran0609@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 |
Primary Hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gomutra Haritaki |
1g thrice daily after food (2 tab of 500 mg in morning, afternoon and evening after food)with modern medicine
Anupana : koshana jala
Duration : 3 months |
| Comparator Agent |
Thyroid hormones |
As per the dose prescribed by the physician |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex with age group 20-60 years.
2. Patients who are diagnosed as primary hypothyroidism.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from systemic diseases like cardiac problems, diabetes, carcinomas etc.
2. Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
3. Pregnant women,patients with hyperthyroidism will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in presenting complaints of weight gain,constipation,pallor, decreased mental and physical activities,hoarseness of voice and others |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in thyroid function test values |
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)
|
01/01/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothyroidism
is one of the most common functional disorders of the thyroid gland. A state of Hypothyroidism can be due
to primary disease of the thyroid gland itself or lack of pituitary TSH
[Thyroid Stimulating Hormone].A keen insight to the pathogenesis of
hypothyroidism according to the principles of Ayurveda, we find that it is basically caused due to dysfunctioning
of the ‘Agni (dhatvagni)’. If we compare various symptoms of hypothyroidism
and Kaphaja Pandu, we find that many
signs and symptoms can be correlated with each other, for example, paleness and dryness of skin, hair fall,
hoarseness of voice, cold intolerance, modest weight gain, reduced appetite,
lethargy, somnolence, puffy face with oedematous eyelids, nonpitting pretibial oedema
etc. So hypothyroidism is similar to Pandu
especially to ‘Kaphaja Pandu’. Gomutra and Haritaki are
having Katu-Tikta-Kashaya Rasa
predominance and Ushna Veerya which act
as Kapha Hara and may help to
breakdown the pathology of Kaphaja Pandu
and hypothyroidism. For this purpose, “GOMUTRA HARITAKI†mentioned by Aacharya Charak in Pandu Chikitsa is selected.
|