| CTRI Number |
CTRI/2019/08/020697 [Registered on: 13/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic treatment for hypothyroidism |
|
Scientific Title of Study
|
An open randomized controlled clinical trial to study the triphala yog in the management of galganda in comparision with thyroxine with special reference to hypothyroidism |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishala R Dodke |
| Designation |
Pg scholar |
| Affiliation |
Y.M.T. Ayurvedic medical college |
| Address |
Department of kayachikitsa, first floor Dr. g.d.Pol Foundation y.m.t.
ayurvedic medical College and hospital, institutional area, sector-4,
kharghar, navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8407934211 |
| Fax |
|
| Email |
dodkevishala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Pandey |
| Designation |
Associate professor |
| Affiliation |
Y.M.T. Ayurvedic medical college |
| Address |
Department of kayachikitsa, first floor Dr. g.d.pol foundation Y.m.t.
ayurvedic medical College and hospital, institutional area, sector-4,
kharghar, navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820006082 |
| Fax |
|
| Email |
drpandeymahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Pandey |
| Designation |
Associate professor |
| Affiliation |
Y.M.T. Ayurvedic medical college |
| Address |
Department of kayachikitsa, first floor Dr. g.d.pol foundation Y.m.t.
ayurvedic medical College and hospital, institutional area, sector-4,
kharghar, navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820006082 |
| Fax |
|
| Email |
drpandeymahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vishala R Dodke |
| Address |
Department of kayachikitsa, first floor Dr. g.d.Pol Foundation y.m.t.
ayurvedic medical College and hospital, institutional area, sector-4,
kharghar, navi mumbai |
| 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 vishala dodke |
Ymt ayurvedic medical college and hospital |
Department of
kayachikitsa, first floor
Dr. g.d.Pol Foundation
y.m.t. ayurvedic
medical College and
hospital, institutional
area, sector-4,
kharghar, navi mumbai
Raigarh
MAHARASHTRA |
8407934211
dodkevishala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Thyroxin |
root of drug administration- orally
dose of drug - 25-100 mcg as per severity of symptoms
Duration of treatment -3 months |
| Intervention |
Triphalayog |
Contents and preparation of Triphalayog
Pippali 3 gm , Kanchanar coarse powder -24 gm , Amalaki -8 gm, Haritaki -8gm , Bibhitaki -8 gm
All the above ingredients will be mixed properly.
1 part of coarse powder i.e. 48 gm + 16
part of water i.e. 768 ml - boil
and reduce to 1/8th part i.e. 96
ml approximately 100 ml and than sprinkle Pippali fine powder 3gm
Root of
drug administration - orally
Dose of drug - 100 ml once a
day Duration of treatment - 3
months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of hypothyroidism
Patients of either gender
Age > 18 years to 80 years
Serum ultrasensitive TSH level >5 micro iu/ml |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients or patients on immunosuppresive drugs
Patients suffering from life threating disease
Pregnancy and lactating mother
K/C/O Thyroid neoplasia, congenital hypothyroidism
Progressive cause of myxoedema coma
Infiltrative disorders like sarcoidosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Triphalayog more effective in management of Hypothyroidsm than Thyroxine |
once in month for three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Triphalayog does not have effect in management of Hypothyroidsm |
Once in a month for three months |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
19/08/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title- an open randomised controlled clinical trail to study the triphala yog in the management of galganda in comparision with thyroxime with special refrence to hypothyroidism.
Trial group - triphala yog
Dose of triphala yog - 100ml orally
Control group - tab thyroxime
Dose of thyroxine - 50 to 100 mcg as per severity of symptoms
Assessment criteria-
Objective criteria - serum TSH, serum t3, serum t4 level, will be done before and after the trial
Subjective criteria - weight gain, amenorrhea, hoarseness of voice, loss of appetite, constipation, somnolence, dyspnoea, debility, dryness, hair loss
|