| CTRI Number |
CTRI/2021/04/033150 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [NASYA & KWATH] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Kanchnar with Shunthi(Dry ginger) oral medication and Nasal therapy of Nimb tail in Hypothyroidism |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Kanchnar twak kwath with Shunthi churna and Nimb tail Nasya in Hypothyroidism |
| Trial Acronym |
Kas Ni Hypo |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRATIMA YADAV |
| Designation |
M.D SCHOLAR |
| Affiliation |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| Address |
DEPARTMENT OF KAYA CHIKITSA AND PANCHAKARMA,
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9451575486 |
| Fax |
|
| Email |
pratimayy12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRATIMA YADAV |
| Designation |
M.D SCHOLAR |
| Affiliation |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| Address |
DEPARTMENT OF KAYA CHIKITSA AND PANCHAKARMA,
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9451575486 |
| Fax |
|
| Email |
pratimayy12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRATIMA YADAV |
| Designation |
M.D SCHOLAR |
| Affiliation |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| Address |
DEPARTMENT OF KAYA CHIKITSA AND PANCHAKARMA,
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9451575486 |
| Fax |
|
| Email |
pratimayy12@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI |
| Address |
DEPARTMENT OF KAYA CHIKITSA AND PANCHAKARMA, GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
| 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 |
| Dr AJAY KUMAR |
GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL |
OPD No.8/11 AND IPD OF KAYA CHIKITSA AND PANCHAKARMA, GOVERNMENT P.G. AYURVEDA COLLEGE AND HOSPITAL, VARANASI
Varanasi
UTTAR PRADESH |
9616870871
drajay2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Govt PG Ayurveda College and Hospital, Sampurnanand Sanskrit University, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KANCHANAR TWAK KWATH WITH SHUNTHI CHURNA |
50mL KANCHANAR TWAK KWATH WITH 1gm SHUNTHI CHURNA BEFORE MEAL TWICE A DAY FOR 45 DAYS |
| Intervention |
KANCHNAR TWAK KWATH WITH SHUNTHI CHURNA AND NIMB TAIL NASYA |
50ml KANCHNAR TWAK KWATH WITH 1 gm SHUNTHI CHURNA AND 2 DROPS OF NIMB TAIL NASYA IN EACH NOSTRIL FOR 45 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are newly diagnosed case of Hypothyroidism with increased TSH level.
TSH level > 4.5µIU/ml.
Total serum T4 level less than normal value(total serum T4 - 4.5 to 12.5µg/dl)
Total serum T3 level less than normal value(total serum T3 - 80 to 220 ng/dl)
Patients having clinical features of Hypothyroidism; Puffiness of the face and eyelids, Peripheral edema etc.
|
|
| ExclusionCriteria |
| Details |
Patients who have under gone any type of thyroid surgery.
Patients whose symptoms are worsely aggravated after leaving the modern drug Levothyroxine(for washout period).
Patients suffering from systemic diseases like Cardiac problem,Diabetes,HTN,Carcinomas etc.
Patients suffering from Congenital hypothyroidism and Secondary Hypothyroidism.
Pregnant women,Hyperthyroidism, Neoplasia,Toxic goitre are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease TSH level |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/05/2021 |
| Date of Study Completion (India) |
20/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
TITLE:- A REVIEW OF KANCHNAR TWAK KWATH, SHUNTHI CHURNA AND NIMB TAIL NASYA IN HYPOTHYROIDISM
DOI: 10.51648/jac.23 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is a Interventional open and randomized, group study trial the efficacy of Kanchnar twak kwath with shunthi churna and Nimb tail Nasya in Hypothyroidism.Patients will be randomly selected from OPD and IPD of Department of Kayachikitsa and Panchakarma, Government PG Ayurveda College and Hospital, Varanasi. 60 Patients will be studied under 2 groups having 30 patients in each group: Group 1: 50 ml Kanchnar twak kwath with 1gm Shunthi churna two times in a day before meal. Group 2: 50mL kanchnar twak kwath with 1 gm Shunthi churna two times in a day before meal and 2 drops Nimb tail Nasya in each nostril. 15 days Follow up for symptoms and monthly follow up for Thyroid function test will be done in each group. |