| CTRI Number |
CTRI/2024/09/073249 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of Guggulvadi churna in Hypothyroidism |
|
Scientific Title of Study
|
A Randomized Controlled Clinical trial to evaluate the effect of Guggulvadi Churna in the management of Primary 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 Amirtha Lakshmi T |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College & Hospital |
| Address |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamil Nadu-600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9940032306 |
| Fax |
|
| Email |
amirthalakshmi02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvendu Rout |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College |
| Address |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamil Nadu 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444881980 |
| Fax |
|
| Email |
drsrout@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amirtha Lakshmi T |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur Tamil Nadu 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9940032306 |
| Fax |
|
| Email |
amirthalakshmi02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Amirtha Lakshmi T |
| Address |
Room 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet 600123 Thiruvallur TamilNadu |
| 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 Amirtha Lakshmi T |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no 17 Department of Kayachikitsa Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai 600123
Thiruvallur district
Tamil Nadu
Thiruvallur
TAMIL NADU |
9940032306
amirthalakshmi02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guggulvadi Churna, Reference: Basavarajeeyam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidanga Churnam, Reference: Kaiyyadeva Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
TSH with in the range of 4.6 to 40 mU L
FT4 less than 0.9 ng dL
Anti-TPO less than 9 IU L |
|
| ExclusionCriteria |
| Details |
Low TSH, low FT4
Patients under medications such as Levothyroxine, Amiodarone, Birth control pills.
Patient who underwent thyroidectomy
Grade 2 and 3 goitre
K/C/O. Hypertension
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in tsh and Ft4 levels |
46 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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 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
|
Hypothyroidism is a clinical hypometabolic state which is defined by Low levels of TSH and High FT4. It is characterised by Low metabolic rate, Hairloss, Slowened thinking capacity, weight gain. .On the basis of symptomatology, hypothyroidism can also be established parallel to Medoroga. In Medoroga, all the channels that continuously supply nutrients to other tissues are blocked by Medas. So, further tissues are not properly formed and only Medas is accumulated. Therefore, the patient becomes weak and will be unable to perform any type of function
Guggulvadi Churna containing Shuddha Guggulu, Hareetaki, Vibheetaki, Amalaki, Shunti, Pippali, Maricha, Chitrakamula, Musta,Vidanga, and is indicated in Medo Vikara, Shleshma Vikaras, Madatyayam. This formulation has Katu, Kashaya Rasa, Laghu- Ruksha Guna, Ushna Virya, Katu Vipaka, Kapha Vata Pradhana Tridoshahara in nature. Deepana, Pachana property of the Guggulvadi Churna helps to rekindle the suppressed Jatharagni. This Churna having Medo-Dhatwagni Vardaka action can be highly target specific and effective in Medoroga. In-vitro and animal studies have proven that Guggulu has thyroid stimulating activity
Some of the drugs of this Churna contains Lekhana property which helps to remove excess of Medas and Kapha obstructing the Srotases. Guggulu & Triphala being two of the ingredients, this formulation also exhibits Rasayana property. |