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CTRI Number  CTRI/2022/02/040565 [Registered on: 23/02/2022] Trial Registered Prospectively
Last Modified On: 31/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the effect of KSM-66 Ashwagandha® capsule (300 mg) on Subclinical Hypothyroidism 
Scientific Title of Study   A Prospective, Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha® capsule (300 mg) on Subclinical Hypothyroidism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suhas Kalashetti 
Designation  Principal Investigator 
Affiliation  Shree Samarth Hospital 
Address  Shree Samarth Hospital, 227, Omkar Appts, Karande Chowk, Rasta peth, Pune-411011, Maharashtra, India.

Pune
MAHARASHTRA
411011
India 
Phone  8805387387  
Fax    
Email  skalashetti@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma 
Designation  Director Quality Assurance 
Affiliation  ProRelix Services LLP 
Address  ProRelix Services LLP 102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune, Maharashtra 411052 Pune, India

Pune
MAHARASHTRA
411052
India 
Phone  8124806366   
Fax    
Email  sthasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mr Sohal Pendse 
Designation  Director Operations 
Affiliation  ProRelix Services LLP 
Address  ProRelix Services LLP 102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune, Maharashtra 411052 Pune, India

Pune
MAHARASHTRA
411052
India 
Phone  9890096725   
Fax    
Email  s.pendse@prorelixresearch.com  
 
Source of Monetary or Material Support
Modification(s)  
Ixoreal Biomed, Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India 
 
Primary Sponsor
Modification(s)  
Name  Ixoreal Biomed 
Address  Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Aman Khanna  Aman Hospital and Research Center  Aman Hospital and Research Center, 15, Shashwat, Opp ESI Hospital, Gotri Road, Vadodara, 390021
Vadodara
GUJARAT 		 9904402122

amankhanna1974@gmail.com 
Dr Suhas Kalashetti  Shree Samarth Hospital  Clinical Research Department, Shree Samarth Hospital, 227, Omkar Appts, Karande Chowk, Rasta peth, Pune-411011, Maharashtra, India.
Pune
MAHARASHTRA 		 8805387387

skalashetti@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Aman hospital and research center  Approved 
Royal Pune Independent Ethics Committee   Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sub Clinical Hypothyroidism 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: KSM-66 Ashwagandha®, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo (Starch), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adult males and females of ages ≥ 18 years and ≤60 years .
2.Patients who can and willing to provide written Informed Consent.
3.Patients with diagnosis based on persistently elevated TSH levels (4.6–10.0 mU/L), with fT4 within the reference range.
4. Participant who agree to take Investigational product (IP) till Day 56.
5. Patients having capability of complete compliance and completion of followup .
6. Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
 
 
ExclusionCriteria 
Details  1. Patients Ë‚ 18 years or ˃ 60 years of age.
2.Patients on current prescription of levothyroxine, antithyroid drugs, amiodarone, or lithium
3.Patients having a history or presence of clinically relevant cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
4.Patients with severe mental disorder.
5.Patients with recent thyroid surgery or radioiodine therapy within 1-year of the start date of the study.
6. Patients with recent hospitalization for major illness or elective surgery within 1- year of the start date of the study.
7.Female patients with pregnancy or lactation, intention to become pregnant, and/or not using appropriate contraceptive methods.
8.Patients with terminal illness.
9.Patients with history of alcoholism or substance abuse.
10. Patients who are not willing to take investigational product.
11. Patients on dietary supplements/multivitamins or disease-specific oral nutrition supplements.
12. Patients with uncontrolled, unstable comorbidities.
13. Patients with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.
14. Patients taking part in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.
15. Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities.
16. Patients who had participated in other clinical trials during previous 3 months
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Standard TSH, T3, T4   Baseline and Day 56  
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in SF 12 (QoL) between baseline and end of treatment.
2.Change in QoL-THY between baseline and end of treatment
3.Change in PSQI between baseline and end of treatment.
4.Change in MMSE score between baseline and end of treatment.
5.Severity of AEs between groups.
6.Frequency of AEs between groups.
7.Patient’s Global Assessment of Tolerability to Therapy (PGATT). 		 Baseline and Day 56  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/02/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicale 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Sixty healthy male or female subjects of age 18-60 will be assigned in 1:1 ratio to treatment with the test product, KSM-6 Ashwagandha capsules or Placebo in this double-blind, randomized, placebo-controlled study. All 60 enrolled subjects will be instructed to take two capsules of either KSM-66 Ashwagandha or Placebo twice a day one capsule after breakfast and one capsule after dinner for 56 days daily. Subjects will be required to use diaries to document the date, time and dosage of study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with TSH, T4 and T3 in blood and secondarily with administration of THY questionnaire, SF 12, PSS 10, MMSE, PSQI and PGATT. 
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