CTRI Number |
CTRI/2023/07/054616 [Registered on: 03/07/2023] Trial Registered Prospectively |
Last Modified On: |
27/02/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To study the effect of Pippali Churna and Shad-dharana Churna in the management of Hypothyroidism |
Scientific Title of Study
|
An open labelled randomized comparative clinical trial of Pippali Churna and Shad-dharana Churna in the 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 |
Snehalben Baria |
Designation |
PG Scholar |
Affiliation |
Government Akhandanand Ayurveda College and Hospital |
Address |
OPD NO 4 Kayachikista Department Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat
Ahmadabad GUJARAT 380001 India |
Phone |
9825938166 |
Fax |
|
Email |
snehalbaria97@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Dipti S Purani |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
Government Akhandanand Ayurveda College and Hospital |
Address |
OPD NO 4 Kayachikista Department Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat
Ahmadabad GUJARAT 380001 India |
Phone |
9427794040 |
Fax |
|
Email |
diptipandya73@yahoo.in |
|
Details of Contact Person Public Query
|
Name |
Dr Dipti S Purani |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
Government Akhandanand Ayurveda College and Hospital |
Address |
OPD NO 4 Kayachikista Department Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat
Ahmadabad GUJARAT 380001 India |
Phone |
9427794040 |
Fax |
|
Email |
diptipandya73@yahoo.in |
|
Source of Monetary or Material Support
|
Government Akhandanand Ayurveda College and Hospital |
|
Primary Sponsor
|
Name |
Government Akhandanand Ayurveda College |
Address |
OPD NO 4, Kayachikista Department,Government Akhandanand Ayurveda College, Bhadra ,Ahmedabad,Gujarat |
Type of Sponsor |
Government 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 Snehal Baria |
Government Akhandanand Ayurveda Hospital |
OPD NO 4, Kayachikista Department, Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat Ahmadabad GUJARAT |
9825938166
snehalbaria97@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:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: DISEASES OF ENDOCRINE SYSTEM, (2) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: DHATUVAISHAMYAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shad-dharana, Reference: Susruta Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippali , Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patient having clinical features of Hypothyroidism or patient who is already taking levothyroxine medicine.
Chronicity of Hypothyroidism below 10 years.
S.TSH>5 mIU/L
|
|
ExclusionCriteria |
Details |
Patient with the age below 18 years and above 60 years.
Patients having any other major systemic diseases like Cancer, Tuberculosis, Type I Diabetes mellitus, Malignant hypertension, Thyrotoxicosis, Asthma, Heart disease, Pregnancy or any other debilitating disease which may lead to fatal condition for the patient at any time.
Patient having history of peptic ulcers, bleeding ulcers etc.
Patient with congenital or secondary Hypothyroidism or goiter.
Patients taking medicine for Hypothyroidism for more than 10 years.
If S.TSH level is more than 100mIU/L
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in sign and symptoms |
56 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Results will be assessed on the basis of TSH score |
56 days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
11/07/2023 |
Date of Study Completion (India) |
10/09/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Hypothyroidism is one of the most common and challenging disease in today’s era. Hypothyroidism is a condition in which the thyroid gland does not produce enough Thyroxine(T4) and Tri-iodothyronine (T3). The prevalence of Hypothyroidism in India is about 11% of population. It is more prevalent in women than in male. Women are affected approximately six times more frequently than men. Hypothyroidism may result from inadequate function of the gland itself (primary Hypothyroidism), inadequate stimulation by thyroid-stimulating hormone from the pituitary gland (secondary Hypothyroidism), or inadequate release of Thyrotropin releasing hormone from the brain’s hypothalamus (tertiary Hypothyroidism). Hashimoto’s Thyroiditis is the most common type, which have an autoimmune pathology. The other causes include thyroid radioactive iodine therapy, surgical removal of thyroid gland, drug induced, TSH deficiency etc. Hypothyroidism is the second most common endocrine disorder observed all over world in present era. The standard treatment in Allopathy for Hypothyroidism is thyroid hormone supplement therapy with levothyroxine. Management of Hypothyroidism with the modern drugs may bring the value of TSH and Thyroxine(T4) to normal range. The prolonged and increased dose of synthetic thyroxine may cause serious long term side effects or any other acute or chronic complications. So, to decrease the dosage of levothyroxine and to get rid of lifetime medication, we have a scope for Ayurvedic medicine. Thyroid hormone act as catalyst for metabolism in whole body. In Hypothyroidism, deficiency of thyroid hormone occurs which causes imbalance in metabolism leading to Dhatwagnimandya in terms of Ayurveda. The symptoms are Kapha-Vatapradhana. So, as per principles of Ayurveda, treatment should be Kapha Shamana, Vata Shamana and Agni dipana. |