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CTRI Number  CTRI/2023/07/054940 [Registered on: 07/07/2023] Trial Registered Prospectively
Last Modified On: 10/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ashwagandha and Selenium combination as a supplement in patients with subclinical hypothyroidism 
Scientific Title of Study   A double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of Ashwagandha and Selenium combination as a supplement in patients with subclinical hypothyroidism. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CW/108/ASH_SCHT/I/JAN/22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. T.V.S Pradeep 
Designation  Principal Investigator 
Affiliation  NUHA Hospitals 
Address  Department of Endocrinology- NUHA Hospital No 12-19-61&62, Old Bank Road, Kothapet, Guntur-522001, Andhra Pradesh, India

Guntur
ANDHRA PRADESH
522001
India 
Phone  9885411254  
Fax    
Email  doctvspradeep@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami-Sabinsa Group limited 
Address  #19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore- 560058

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  satish.g@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami-Sabinsa Group limited 
Address  #19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore- 560058

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  satish.g@clinworld.net  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. 
 
Primary Sponsor  
Name  Sami Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, Peenya II Phase, Bengaluru, Karnataka 
Type of Sponsor  Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T V S Pradeep  NUHA Hospitals   Department of Endocrinology- NUHA Hospital No 12-19-61&62, Old Bank Road, Kothapet, Guntur-522001, Andhra Pradesh, India
Guntur
ANDHRA PRADESH 		 9885411254

doctvspradeep@gmail.com 
Dr Prashanth BV  Sapthagiri Institute of Medical Sciences and Research Center  Department of General Medicine, #15, Chikkasandra, Hesarghatta Main road, Bangalore
Bangalore
KARNATAKA 		 09380060234

prashi99@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committe of NUHA Hospitalse  Approved 
Sapthagiri Institute of Medical Sciences and Research Center Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  500 mg of Microcrystalline cellulose.  One Capsule once a day after dinner for 90 days  
Intervention  Ashwagandha 500mg & Selenium 40mcg  one capsule once a day after dinner for 90 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and Female participant age ≥18 and ≤ 60 years
2. Patients with serum T3, T4 within Normal Range but serum TSH to be more than Normal (≥ 4.6 µIU/mL - ≤ 10 µIU/mL)
3. Participant should be willing to provide a written and signed informed consent and comply with requirements of the trial.
4. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.

 
 
ExclusionCriteria 
Details  1. Patients under any allopathic or non-allopathic treatment for Subclinical or clinical hypothyroidism.
2. Patients suffering from any other systemic illness viz. diabetes, HTN, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
3. Patients undergoing treatment for any other systemic illness.
4. Patient who had Thyroid surgery or radioiodine therapy.
5. Lactating Women & women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
6. Patients with Polycystic ovary syndrome (PCOS).
7. BMI ≤18.5 or ≥35 kg/m2.
8. History of chronic smoking and Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
9. Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period.
10. Any other condition that the Principal Investigator thinks may jeopardize the study.




 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Mean change in Serum TSH levels.
 		 1. Screening Visit to Day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean change in Serum T3 levels.
2. Mean change in Serum T4 levels
3.Mean change in anti-thyroid peroxidase antibody
4.Mean change in Lipid Profile
5.Mean change in BMI
6.Safety as determined through changes in complete blood count (CBC) blood biochemistry tests results & incidence of adverse events during the study period in both arms. 		 1. Screening Visit to Day 90
2. Screening Visit to Day 90
3. Day 0 to Day 90
4. Screening Visit to Day90
5. Day 0 & Day 90
6. Screening to Day90
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/07/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   After completion of screening assessments. All eligible patients who meet the Inclusion and Exclusion criteria will be enrolled in the study. 
 
 The trial participants are randomly assigned to either of the two study arms on a 1:1 ratio and the participating subjects are advised to take a capsule that may contain either Ashwagandha + Selenium combination or a Placebo for a period of 90 days 

Visit 1- for Screening (Day -5), –Visit-2 (Day 0)- for Randomization/Enrollment, Visit 3- (Day 30 ± 5 days) for 1st follow-up; Visit 4-(Day 60) ± 5 days for 2nd follow up and Visit 5-(Day 90-±5 days) for last visit. 

Blood samples for Hematology, Liver function, Renal function, Lipid profile, FBS & HbA1c will be collected at visit 1 & visit 5.

Thyroid function test (Serum TSH, serum T3, serum T4) will be done at visit 1, visit 3, visit 4 & visit 5. Samples for Anti Thyroid Peroxidase test will be collected at visit 2 & visit 5.

 
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