| CTRI Number |
CTRI/2025/04/086025 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study the effect of Shigru patra Churna in Primary Hypothyroidism |
|
Scientific Title of Study
|
An open labelled controlled clinical trial to study the effect of Shigru patra 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 Pallavi Vinayak Jadhav |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital dhamangaon igatpuri nashik |
| Address |
Department of Kayachikitsa SMBT Ayurved College and Hospital
Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8975395188 |
| Fax |
|
| Email |
dr.pallavijadhav1603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayuri Sunil Pawar |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital dhamangaon igatpuri nashik |
| Address |
Department of Kayachikitsa SMBT Ayurved College and Hospital
Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8668549430 |
| Fax |
|
| Email |
dr.mayuripawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Vinayak Jadhav |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital dhamangaon igatpuri nashik |
| Address |
Department of Kayachikitsa SMBT Ayurved College and Hospital
Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8975395188 |
| Fax |
|
| Email |
dr.pallavijadhav1603@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa SMBT Ayurved College and Hospital
Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
|
|
Primary Sponsor
|
| Name |
Dr pallavi Vinayak Jadhav |
| Address |
Department of Kayachikitsa SMBT Ayurved College and Hospital
Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Type of Sponsor |
Other [Self (individual)] |
|
|
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 Pallavi Vinayak Jadhav |
SMBT AYURVEDA COLLEGE AND HOSPITAL |
OPD NO 20 Department of Kayachikitsa SMBT Ayurved College and Hospital
Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA |
8975395188
dr.pallavijadhav1603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
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: Shigru patra churna, Reference: Bhavprakash purva khanda chapter guduchyadi varga sholka no 105 to 107, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Thyroxine | Dose 50 microgram Frequency Once a day in morning with water Duration 90 days Route Oral |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fulfilling the laboratory diagnosis of primary hypothyroidism
based on the levels of serum TSH, T3, and T4.
2.Patients having TSH level less than 15 mIU/L
3.Patient who are freshly diagnosed as hypothyroidism.
4.Patients who are already diagnosed Hypothyroidism and under
Thyronorm (Levothyroxine) medication 50 µgm but presenting with
diagnostic criteria are included.
|
|
| ExclusionCriteria |
| Details |
1.Individuals diagnosed with diabetes mellitus, ischemic heart disease,
uncontrolled hypertension, myocardial infarction, cerebrovascular
incidents, cardiac arrhythmias, those who are pregnant, and patients
with active malignant diseases were not included in the study.
2.Individuals exhibiting modified thyroid hormone levels as a result of
various conditions, including under nutrition, malignant neoplasms, or
non-thyroidal illnesses (commonly referred to as low-T3 syndrome).
3.Patients having TSH level greater than 15 mIU/L.
4.Recent thyroid surgery (within 12 months).
5.Patients suffering from diseases like HIV, TB, Encephalopathy, Goiter, Other
endocrine disorders and other autoimmune disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in signs and symptoms and decreasing TSH level in Primary Hypothyroidism
after ingestion of Shigru patra churna |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Where the trial group stands in comparison with
control group
|
18 months |
|
|
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 |
|
Date of First Enrollment (India)
|
13/05/2025 |
| 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
|
Hypothyroidism is a medical condition characterized by the inadequate production
of thyroid hormones by the thyroid gland. These hormones are thyroxine (T4) and
triiodothyronine (T3). Galaganda primarily arises from Kaphaavritavata, exhibiting symptoms such as
Shaitya, Gaurava, and Shopha, which can be associated with weight gain and
edema commonly seen in hypothyroidism. The prevalence of hypothyroidism in Maharashtra is 10.95%. Shigru patra churna has Kapha Vatahara , Deepan, Shothahara & Medohara properties, with specific indication in
galaganda. The assessment of effect of Shigru patra churna in patients of primary hypothyroidsim is the chief objective of the study with the replacement of the
modern drugs by a safe and effective alternative in Ayurveda. Moringa oleifera dry leaf powder is a source of the essential amino acid tyrosine, which is crucial for the synthesis of thyroid hormones.The patients within the age group of 18- 50 years who fulfills the clinical diagnostic criteria for Primary Hypothyroidism & having symptoms of Primary Hypothyroidism as mentioned in classics are selected irrespective of sex, socio-economic status, and community, written consent from patient will be taken prior to study. Total 70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group). Group A - shigru
patra churna 4 gm BD & Group B- tab . Thyroxine 50 µgm will be given to patients. Both drugs will be administered for 90 days. Observations will be done on day 0,day 30 day 60, day 90 . Result of study will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. |