| CTRI Number |
CTRI/2024/12/078289 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of Triphaladya Guggulu Along with Thyroxine in Reducing Thyroid-Stimulating Hormone (TSH) Levels in Patients with Hypothyroidism |
|
Scientific Title of Study
|
Study The Efficacy Of Triphaladya Guggulu As Add-On Therapy With Thyroxine 25 Mcg In Patients Of Hypothyroidism On TSH Level |
| 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 Anand Pramod Rahangdale |
| Designation |
M.D. Scholar Kayachikitsa Department |
| Affiliation |
Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003
Nashik
MAHARASHTRA
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8390046600 |
| Fax |
|
| Email |
anand.rahangdale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Popat V Jagtap |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Kayachikitsa, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 420003
Nashik
MAHARASHTRA
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Popat V Jagtap |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Kayachikitsa, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 420003
Nashik
MAHARASHTRA
422003
India
MAHARASHTRA
422003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Medical College And Hospital , KamalNagar , Hirawadi , Panchwati,
Nashik |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Kayachikitsa, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 420003 |
| Type of Sponsor |
Private medical college |
|
|
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 Anand Pramod Rahangdale |
Shree Saptashrungi Ayurved Mahavidyalaya |
Department of Kayachikitsa, Shree Saptashrungi
Ayurved Medical
College And Hospital,
KamalNagar , Hirawadi
, Panchawati , Nashik
422003
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
8390046600
anand.rahangdale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik |
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: Triphaldya Guggulu, Reference: Shastri LP. Yogratnakara. Gandamala‑apchi chikitsa. In: Triphladya Guggulu. Vol. 1‑2. Varanasi: Chaukhamba Prakashan; 2013. p. 150, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Thyroxine 25 mcg | Route: Oral, Dosage Form: Tablets, Dose: 25 mcg, Frequency: OD, Duration: 30 Days. TABLET WILL BE GIVEN OD (BEFORE FOOD) |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having at least 3 clinical features of Hypothyroidism among following –
Symptoms-
Tiredness.
Dry skin
Feeling cold
Hairfall
Difficulty in concentration and poor memory
Weight gain with poor appetite
Dyspnea
Hoarse voice
Impaired hearing.
Signs -
Dry coarse skin , cool peripheral extremities
Puffy face, hands and feets.
Diffuse alopecia
Bradycardia.
Peripheral edema. |
|
| ExclusionCriteria |
| Details |
Hypertension
Hyperthyroidism
Pregnancy
Lactation
DM
IHD
Patients undergoing any known hormonal therapy.
Malignancy
Any surgical pathology. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduce The Symptoms Of Hypothyroidism.
TSH level before and after will be assessed.
Following will also be assessed-
1. tiredness
2. hair loss by hair pull test
3. constipation
4. oedema |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce The Symptoms Of Hypothyroidism like tiredness , hair loss , oedema . BMI will be assessed |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/12/2024 |
| 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 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
|
OBJECTIVES Primary Objective: - To study the add-on effect of Triphaladya Guggulu given along with Thyroxine ,on TSH level .
- To study the effect of Thyroxine on TSH.
- To compare the effect of Triphaladya Guggulu given along with Thyroxine with that of Thyroxine alone in the patient of Hypothyroidism.
Other Objectives - To review and study the literature of Galganda-Gandmala.
- To review and study the literature of Hypothyroidism.
- Any new theoretical and practical concept if found during study will be noted down
PARTICIPANTS 40 Adults diagnosed with Hypothyroidism meeting inclusion and exclusion criteria from OPD and IPD of department of Kayachikitsa of Shree Saptashrungi Medical College and Hospital Nashik
Interventions 20 patients Oral administration of Triphaladya Guggulu 2 tab BD with Tab Thyroxine 25mcg BD 20 patients Oral administration of Tab Thyroxine 25mcg BD
Outcome : Reduce the sign and symptoms of Hypothyroidism
Treatment Duration : 30 Days Follow Up :0th , 15th , 30th Days
Data Analysis : Data will be analyzed using appropriate statistical methods to compare the
effectiveness of the intervention on the primary and secondary outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with
informed consent from participants. |