| CTRI Number |
CTRI/2024/02/063328 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| 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
|
Use of Vyoshadi Guggulu and Thyroxine Sodium Tablet in management of Hypothyroidism. |
|
Scientific Title of Study
|
Randomised comparative clinical controlled assessment Of Vyoshadi Guggulu and Thyroxine Sodium Tablet in management of 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 Haresh Dattatray Sable |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College |
| Address |
OPD No.14 Kayachikitsa Department,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8390974633 |
| Fax |
|
| Email |
drhareshsable1122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sathe |
| Designation |
Associate professor of Kayachikitsa department |
| Affiliation |
Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College |
| Address |
OPD No.14 Kayachikitsa Department,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9819216230 |
| Fax |
|
| Email |
vdaparnasathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haresh Dattatray Sable |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College |
| Address |
OPD No.14 Kayachikitsa Department,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8390974633 |
| Fax |
|
| Email |
drhareshsable1122@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Haresh Dattatray Sable |
| Address |
OPD No.14 Kayachikitsa Department,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.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 Haresh Dattatray Sable |
Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College |
OPD No.14 Kayachikitsa Department,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA |
8390974633
drhareshsable1122@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:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Guggulu, Reference: Brihat Nighantu Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 12(g), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Thyroxine Sodium Tablet | Route-Oral,Dosage Form- Tablet,Dose- As per TSH level(1.6 mcg/body weight) Frequency -OD,Duration-6weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Serum Ultrasensitive level 5 – 15 micro IU/ML
2.Freshly diagnosed cases of Hypothyroidism.
3.Subject having one or more classical symptoms.
4.Patient of either gender.
5.Age 18 years and 40 years.
|
|
| ExclusionCriteria |
| Details |
1.Immunocompromised patients or patients on immunocompressive drugs .
2.Patients suffering from life threatening diseases.
3.Pregnancy and lactating mother.
4.K/C/O Thyroid Neoplasia.
5.Progressive cases of Myxoedema coma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the symptomatic relief.
2.To observe the changes in TSH level.
|
The Study will be conducted for 6 weeks.
Clinical Assessment after every 2 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the association of hypertriglyceremia in Hypothyroidism & effect of Vyoshadi Guggulu on it.
2.To study the Probable mode of action of Vyoshadi Guggulu in management of Hypothyroidism.
|
Study will be conducted for 6 weeks.
follow up on 0th week,2nd week,4th week,6th week.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The current study aimed as randomised control parallel group trial comparing the efficacy Vyoshadi Guggulu and Thyroxine Sodium Tablet in the management of Hypothyroidism.Total 70 diagnosed patients of Hypothyroidism are equally divided into two groups,namely experimental and control group.The symptoms of Hypothyroidism weight gain in last 6 months,loss of hairs,dyspnoea,puffiness on face.Vyoshadi guggulu 12gm used as experimental group medicine for single use at night time will be given for 6 weeks. Thyroxine Sodium Tablet(As per TSH level 1.6mcg/body weight)used as control group medicine for single use at morning(empty stomach) will be given for 6 weeks. The study will be conducted for 6 weeks. clinical assessment after every 2 weeks. Hypothyroidism is one of the most common thyroid disorders in india,affecting one in ten adults.In Ayurveda parlance,this is attributed as the function of agni(system related to metabolism).In modern science,the treatment of hypothyroidism is done by thyroxine hormone therapy for long time but this medication can lead to several side effects like chest pain or discomfort,difficult or laboured breathing,extreme fatigue,irritability etc.However in recent times,hypothyroidism can be well managed with ayurvedic medication.Vyoshadi Guggulu has deepan pachan quality which pops body metabolism and also have thyroid stimulatory properties. The content of Vyoshadi Guggulu are easily available and cost effective in nature hence selected for the present study. |