| CTRI Number |
CTRI/2024/11/076456 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of
NavakGuggulu along with Thyroxin in Hypothyroidism |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Add On Effect Of Navaka Guggulu Along With Thyroxine In 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 Revati Pradeep Dhawadkar |
| Designation |
P.G. Student |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D. NO. 2 Kayachikitsa Department First Floor Saneguruji Arogya
Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9764440635 |
| Fax |
|
| Email |
revatidhawadkar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Sujay Patil |
| Designation |
Associate Professor |
| Affiliation |
Mams Sumatibhai Shah Ayurved Cllege Hadapsar Pune |
| Address |
OPD NO 2 Kayachikitsa Department First Floor Saneguruji Arogya
Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9665429186 |
| Fax |
|
| Email |
drvrmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Sujay Patil |
| Designation |
Associate Professor |
| Affiliation |
Mams Sumatibhai Shah Ayurved Cllege Hadapsar Pune |
| Address |
OPD NO 2 Kayachikitsa Department First Floor Saneguruji Arogya
Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9665429186 |
| Fax |
|
| Email |
drvrmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Arogya Mandals Sumatibhai Shah Ayurved College OPD no 2 Kayachikitsa
Department First Floor Saneguruji Arogya Kendra Malwadi Hadapsar Pune 411028 Maharashtra
INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Revati Pradeep Dhawadkar |
| Address |
OPD no 2 Kayachikitsa Department First Floor Saneguruji Arogya
Kendra Malwadi Hadapsar Pune 411028 Maharashtra INDIA |
| 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 Revati Pradeep Dhawadkar |
Sane Guruji Arogya Kendra |
OPD No.2, Kayachikitsa Department, Sane Guruji Aarogya Kendra,Malwadi Hadapsar,Pune
Pune
MAHARASHTRA |
9764440635
revatidhawadkar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Thyroxin | 1.5 microgram per Kg per body weight | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu, Reference: Bhaishajya Ratnavali Medorog Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
2) Known case of Hypothyroidism.
3) Gender - both male and female patients will be selected irrespective of religions and economical status. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from co-morbid or life threatening eliments.
2.Congenital hypothyroidism or anatomical deformity related to thyroid gland
3.Known case of thyroid neoplasia.
4.Progressive case of myxoedema coma.
5.Infiltrative disorders like sarcoidosis etc
6.Individual suffering from immune compromised diseases or patients on immunocompressive drugs.
7.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Weight gain/month
2 Amennorrhea
3 Loss of appetite
4 Constipation
5
Hoarseness of voice
6 Somnolence (Duration of sleep)
7 Dyspnoea
8 Quantity of menstrual flow
9 Duration of menstrual bleeding
10 Debility
11Dryness of skin
12Hair loss
13. Thyroid Function test |
Inclusion day, 30th day, 60th day, 90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effect of the Ayurvedic drug if any. |
Inclusion day, 30th day, 60th day, 90th day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="33"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypothyroidism is a hypo metabolic clinical state resulting from inadequate
production of thyroid hormones for prolonged periods or rarely, from resistance of the
peripheral tissues to the effects of thyroid hormones. Its incidence is increasing day by
day and its name became common on the tongue of society. It effects the body
Physiology as well as psychology. It occurs about five times more often in females than in
males1. In the vast majority of cases Hypothyroidism (approximately 99%) results from an
intrinsic disorder of the thyroid gland (primary Hypothyroidism) |