| CTRI Number |
CTRI/2019/07/020457 [Registered on: 31/07/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
management of hypothyroidism through polyherbal medicine |
|
Scientific Title of Study
|
Clinical evaluation of a poly herbal compound 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 Alok kumar srivastava |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, U.A.U, Haridwar |
| Address |
Rishikul Campus, Dept. of panchkarma,U.A.U, Haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9045087121 |
| Fax |
|
| Email |
virgo.alok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok kumar srivastava |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, U.A.U, Haridwar |
| Address |
Rishikul Campus, Dept. of panchkarma,U.A.U, Haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9045087121 |
| Fax |
|
| Email |
virgo.alok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok kumar srivastava |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, U.A.U, Haridwar |
| Address |
Rishikul Campus, Dept. of panchkarma,U.A.U, Haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9045087121 |
| Fax |
|
| Email |
virgo.alok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus UAU haridwar |
|
|
Primary Sponsor
|
| Name |
Rishikul campus |
| Address |
Rishikul campus, U.A.U, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vandana |
OPD & IPD of dept. of panchkarma rishikul campus. |
rishikul campus U.A.U Haridwar
Hardwar
UTTARANCHAL |
9410100647
vandanachauhan965@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
jalkumbhi bhasma - 500mg BD, panchkol churna- 5gm BD, brahmi churna-3gm BD and ashwagandha churna-3gm BD |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of hypothyroidism. |
|
| ExclusionCriteria |
| Details |
1. patient having any systemic complicated illness.
2. uncontrolled DM with complications like nephropathy.
3. uncontrolled HTN or with complications.
4. known cases of IHD, CHF and or vascular disorders.
5. pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marked improvement: 76%-100%
Moderate improvement: 51%-75%
Mild improvement: 26%-50%
No improvement: 0%-25%. |
Marked improvement:76%-100%
Moderate improvement:51%-75%
Mild improvement:26%-50
No improvement 0%-25% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacaberation in signs and symptoms. |
1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Trial is going on. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial is going on.The trial is clinical evaluation of a polyherbal compound in the management of hypothyroidism. hypothyroidism is progressive disorder of thyroid gland.autoimmunity plays a significant role in this disease.In ayurveda polyherbal compound are very effective in hypothyroidism. |