FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083074 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study Of Satyanashi in Hypothyroidism 
Scientific Title of Study   Clinical Evaluation Of Efficacy Of Swarnaksheeri Beeja Yoga in the management of Galaganda WSR to 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 Goli Lakshmi Manasa 
Designation  PG SCHOLAR 
Affiliation  Dr N R S Government Ayurvedic College Vijayawada A P 
Address  Department Of Rasa Shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College Vijayawada Andhra Pradesh
Krishna Andhra Pradesh 520002 India
Krishna
ANDHRA PRADESH
520002
India 
Phone  8465905098  
Fax    
Email  golilakshmimanasa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Sreehari 
Designation  Professor of Rasa Shastra and Bhaishajya Kalpana 
Affiliation  Dr N R S Government Ayurvedic College Vijayawada A P 
Address  Department Of Rasa Shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College Vijayawada Andhra Pradesh
Krishna Andhra Pradesh 520002 India

ANDHRA PRADESH
520002
India 
Phone  9491925109  
Fax    
Email  dr.skovi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Goli Lakshmi Manasa 
Designation  PG SCHOLAR 
Affiliation  Dr N R S Government Ayurvedic College Vijayawada A P 
Address  Department Of Rasa Shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College Vijayawada Andhra Pradesh
Krishna Andhra Pradesh 520002 India

ANDHRA PRADESH
520002
India 
Phone  8465905098  
Fax    
Email  golilakshmimanasa@gmail.com  
 
Source of Monetary or Material Support  
Department of Rasashastra and Bhaishajya kalpana Dr NRS Govt. Ayurvedic College MG road, Vijayawada, Andhra pradesh,India, 520002. 
 
Primary Sponsor  
Name  Dr Goli Lakshmi Manasa 
Address  Department of Rasa shastra and bhaishajyakalpana Dr N.R.S Govt Ayurvedic college M.G road Vijayawada Andhra pradesh 520002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G LAKSHMI MANASA  Dr Achanta Lakshmipathi Government Ayurvedic Hospital   OPD NO.5,Kayachikitsa vibhaga,Dr Achanta Lakshmipathi Government Ayurvedic Hospital, M.G road near vijaya krishna super bazar Vijayawada Andhra Pradesh 520002 India
Krishna
ANDHRA PRADESH 		 8465905098

golilakshmimanasa@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Swarnaksheeri beeja yoga, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Duration of illness less than 1 year.
2.presence of signs and symptoms of Galaganda, Hypothyroidism.
3.Presence of abnormal thyroid profile. 
 
ExclusionCriteria 
Details  1.Duration of disease more than 1year.
2.Carcinoma of Thyroid.
3.Injury to hypothalamus or anterior pitutary gland.
4.Congenital lack of functional thyroid gland.
5.Previous Thyroid surgery.
6.Pregnant, lactating female.
7.Persons with IBS and loose stools. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
relief of symptoms and significant improvement of objective parameters tests.   1month with regular follow up every week  
 
Secondary Outcome  
Outcome  TimePoints 
scoring and grading for assessment  weekly follow up for 1month 
 
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   N/A 
Date of First Enrollment (India)   01/05/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [golilakshmimanasa@gmail.com].

  6. For how long will this data be available start date provided 17-01-2026 and end date provided 17-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

NEED FOR STUDY:

Hypothyroidism leads to a series of pathological events and makes the affected person to remain dependant on hormonal supplement till the end of mortal life. Ayurvedic physician prescribes some basic remedies of Galaganda-Gandamala-Aapchi in the Ayurvedic classics. Hypothyroidism may have various aspects like Dhatavagni Vikriti, Medoroga , Shotha (Ekanga) and Galaganda .

There is a need to study Hypothyroidism critically with special reference of Galaganda,so as to get a proper line of treatment with herbal,mineral or Herbomineral Compound to treat in future.

Hence this study has been taken to study the effect of Swarna ksheeri Beeja yoga on Galaganda wsr to hypothyroidism so as to eliminate the need of patient being dependent on the hormonal supplements for the lifetime.

 

 
Close