| CTRI Number |
CTRI/2025/07/091362 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| 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
|
Effect of Aparajita Arka in Galaganda with special reference to hypothyroidism |
|
Scientific Title of Study
|
Efficacy of Aparajita Arka in Galaganda with special reference
to Hypothyroidism A Randomized Controlled Clinical Trial |
| 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 Sushree Saswati Nayak |
| Designation |
PG SCHOLAR |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Shalakyatantra OPD number 26 and 27 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur
Belgaum
KARNATAKA
590001
India |
| Phone |
09583411120 |
| Fax |
|
| Email |
sushreenyk55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KSSangolli |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Shalakyatantra OPD number 26 and 27 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur
Belgaum
KARNATAKA
590001
India |
| Phone |
9448266968 |
| Fax |
|
| Email |
drksskle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KSSangolli |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Shalakyatantra OPD number 26 and 27 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur
Belgaum
KARNATAKA
590001
India |
| Phone |
9448266968 |
| Fax |
|
| Email |
drksskle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra OPD number 26 and 27 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur belagavi 590001 karnataka India |
|
|
Primary Sponsor
|
| Name |
Institution |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur belagavi 590001 karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sushree S Nayak |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
Department of Shalakyatantra OPD number 26 and 27 KAHERs Shri BMK Ayurveda Mahavidyalaya
Belgaum
KARNATAKA |
9583411120
ssnayak55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe for research on human subjects |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchanara Guggulu, Reference: Shri Ambikadatta Shastri Bhaisajya Ratnavali Varanasi Chaukhambha Prakashan 2019 Page no 625 , Route: Oral, Dosage Form: Guggulu , Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aparajita , Reference: Tripathi Indradev Arka prakasha of Ravana 1st ed Varanasi Chaukhambha krishnadas academy 1995 Shasta Satakam Page no 94, Route: Oral, Dosage Form: Arka, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with TSH level of greater than 4.5 ml U per L AACE but below 20ml U per L |
|
| ExclusionCriteria |
| Details |
TSH level more than 20ml U per L
Pregnant women goiter associated with metastasis condition
Patient under Hypothyroidism medication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Efficacy of Aparajita Arka in the management of Galaganda Chikitsa wsr to Hypothyroidism |
30 Days of intervention and followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the effect of Aparajita Arka with Kanchanara Guggulu in the management of Galaganda chikitsa wsr to Hypothyroidism |
30 Days of intervention and followup |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="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
|
Hypothyroidism is believed to be a common health issue in India as it is present worldwide. The prevalence of hypothyroidism was high, affecting approximately one in 10 adults in the study population. Female gender and older age were found to have significant association with hypothyroidism and clinical manifestations of hypothyroidism range from life threatening to no signs or symptoms. The most common symptoms in adults are fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin, but clinical presentation can differ with age and sex. According to Charaka presentation of multiple Granthi around the neck is called Gandamala and single swelling on the Parshva of the neck is Galaganda. Review of literature The most common cause of hypothyroidism is the inability of the thyroid gland to produce a sufficient amount of thyroid hormone however less commonly pituitary and hypothalamus impairment may also result in thyroid dysfunction. The hypothalamus secretes thyrotropin releasing hormone (TRH) that stimulates the pituitary gland to produce thyroid-stimulating hormone (TSH). Thyroid-stimulating hormones stimulate the thyroid gland to produce and secrete mainly T4, approximately 77 to 155 nmol/L, and smaller quantities of T3 of 1.2-2.8 nmol/L. AIM: Effect of Aparajita Arka in the management of Galaganda Chikitsa w.s.r to Hypothyroidism OBJECTIVE OF THE STUDY: Primary Objective : To evaluate the Efficacy of Aparajita Arka in the management of Galaganda Chikitsa w.s.r to Hypothyroidism. Secondary Objective : To Compare the effect of Aparajita Arka with Kanchanara Guggulu in the management of Galaganda chikitsa w.s.r to Hypothyroidism . HYPOTHESIS: H0: Aparajita Arka is not comparable to Kanchanar guggulu in the management of Galaganda w.s.r to Hypothyroidism . H1: Aparajita Arka is comparable to Kanchanar guggulu in the management of Galaganda w.s.r to Hypothyroidism. RESEARCH QUESTION: Whether the Aparajita Arka is effective in the management Galaganda w. s. r to Hypothyroidism intake daily for a period of 30 days? EXPECTED OUTCOME: May help in the reduction of signs and symptoms
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