CTRI

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CTRI Number

CTRI/2024/11/076307 [Registered on: 05/11/2024] Trial Registered Prospectively

Last Modified On:

28/10/2024

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

To Study The Effect Of Vidangadi Lauha Kalp With Madhu In obese Hypothyroidism patient

Scientific Title of Study

Study Of Efficacy Of Vidangadi Lauha With Madhu As An Add On Effect In The Management Of Hypothyroidism With Obesity

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Shriya Vidhyadhar Kale
Designation	Pg scholar
Affiliation	Government Ayurvedic College Nanded
Address	Department Of Kayachikitsa Government Ayurvedic College And Hospital Nanded Nanded MAHARASHTRA 431601 India
Phone	8605030661
Fax
Email	shriyakale27@gmail.com

Details of Contact Person
Scientific Query

Name	Vd Prasad V Kulkarni
Designation	Assistant professor
Affiliation	Government Ayurvedic College Nanded
Address	Department Of Kayachikitsa Government Ayurvedic College And Hospital Nanded Nanded MAHARASHTRA 431601 India
Phone	9405365096
Fax
Email	kulk.prasad1@gmail.com

Details of Contact Person
Public Query

Name	Vd Prasad V Kulkarni
Designation	Assistant professor
Affiliation	Government Ayurvedic College Nanded
Address	Department Of Kayachikitsa Government Ayurvedic College And Hospital Nanded Nanded MAHARASHTRA 431601 India
Phone	9405365096
Fax
Email	kulk.prasad1@gmail.com

Source of Monetary or Material Support

Self sponsored, Kayachikitsa Department Government Ayurvedic College Nanded Maharashtra 431601 India

Primary Sponsor

Name	Shriya Vidhyadhar Kale
Address	Department Of Kayachikitsa Government Ayurvedic College And Hospital, Nanded 431601 Maharashtra India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shriya Vidhyadhar Kale	Government Ayurvedic College And Hospital Nanded	Room no 18,Kayachikitsa Department Nanded MAHARASHTRA	8605030661 shriyakale27@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Government Ayurvedic College And Hospital Nanded	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E00-E89\|\|Endocrine, nutritional and metabolic diseases. Ayurveda Condition: Hypot,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Vidangadi Lauha , Reference: à¤šà¤°à¤• à¤¸à¥à¤¤à¥à¤° 21/23, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
2	Comparator Arm (Non Ayurveda)		-	Tab Thyroxine	Dose of Tab Thyroxine is prescribed by the physician

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	1.Patients having clinical features of Hypothyroidism. 2.Patients willing to give their consent and participate in the study. 3.Serum TSH level above 4.25mlU/mL. 4.BMI more than or equal to 25 Kg per meter square. 5.Age 18-45 years of either sex. 6.K/C/O Hypothyroidism from less than 10 years. (Anti- Thyroid medications started from at least 3 month before commencement of treatment.)

ExclusionCriteria

Details

1.Patients suffering from Secondary Hypothyroidism, Hashimato Thyroiditis.
2.Pregnancy, lactating mothers.
3.patients having associated diseases like ischemic heart diseases, uncontrolled hypertension, uncontrolled diabetes, myocardial infarction, cerebrovascular events, Cardiac arrhythmias, malignancy and suffering from Psychosis.

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.To assess the role of Vidangadi Lauha with madhu on symptoms of Hypothyroidism. 2.To assess the Medohar property of Vidangadi Lauha with madhu (by changes in BMI)	6 weeks

Secondary Outcome

Outcome	TimePoints
To assess the role of Vidangadi Lauha with madhu in Thyroid stimulating activity (by changes in serum TSH level.)	45 days

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

Phase 2

Date of First Enrollment (India)

09/11/2024

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

This study is randomised, controlled, clinical trial of add on effect of Vidangadi Lauha tablet 250mg BD with madhu after food for 45 days in the Management of Hypothyroidism with Obesity. Follow up will be taken on 0th, 23rd and 46th day.

This study is conducted as PG Course at single centre. The primary outcome is to assess the role of Vidangadi Lauha with madhu on symptoms of Hypothyroidism and to assess the Medohar property of Vidangadi Lauha with madhu (by changes in BMI)