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CTRI Number  CTRI/2024/05/066907 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluating Virechana and Hamsapathyadi Kashayam in Hypothyroidism- A Clinical and Computational Analysis 
Scientific Title of Study   A Clinical and In-Silico Study to Assess the Efficacy of Virechana Followed by Oral Medications and Analysis of Outcomes of Hamsapathyadi Kashayam on THRα And THRβ In 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  Tanzeem Shaikh 
Designation  MD Scholar 
Affiliation  All India Institue of Ayurveda 
Address  7th floor, Department of Panchakarma, All India Institute of Ayurveda, Gautam Puri Awas, Sarita Vihar, Delhi

New Delhi
DELHI
110076
India 
Phone  08369518458  
Fax    
Email  tanzeem.shaikh786.ts@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anandaraman PV  
Designation  Professor, HOD, MS 
Affiliation  All India Institue of Ayurveda 
Address  7th floor, Department of Panchakarma, All India Institute of Ayurveda, Gautam Puri Awas, Sarita Vihar, Delhi

New Delhi
DELHI
110076
India 
Phone  9495130595  
Fax    
Email  dr.ananthramsharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tanzeem Shaikh 
Designation  MD Scholar 
Affiliation  All India Institue of Ayurveda 
Address  7th floor, Department of Panchakarma, All India Institute of Ayurveda, Gautam Puri Awas, Sarita Vihar, Delhi

New Delhi
DELHI
110076
India 
Phone  08369518458  
Fax    
Email  tanzeem.shaikh786.ts@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  7th floor, Department of Panchakarma, All India Institute of Ayurveda, Gautam Puri Awas, Sarita Vihar, Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Tanzeem Shaikh  All India Institute of Ayurveda, Gautam Puri Awas, Sarita Vihar, Delhi  OPD 06, Department of Panchakarma, All India Institute of Ayurveda, Gautam Puri Awas, Sarita Vihar, Delhi 110076
South
DELHI 		 08369518458

tanzeem.shaikh786.ts@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Division of Translational Research and Biostatistics  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: Hypothyrodism,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Charak Samhita Sutrasthana 2/25, Procedure details: Shodhananga Snehapana in increasing doses with the medicated ghritam as per the disease condition is done in the preparatory phase before Virechana.)
(1) Medicine Name: Varunadi Ghritam, Reference: Ashtanga Hrudaya Sutrasthana 15/21-22, Route: Oral, Dosage Form: Ghrita, Dose: 300(ml), Frequency: od, Duration: 1 Weeks
2Intervention ArmDrugClassical(1) Medicine Name: Hamsapathyadi Kashayam, Reference: Anukta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: 60ml boiled and cooled water), Additional Information: -
(2) Medicine Name: kanchanar guggulu, Reference: Bhavaprakasha, Madhyama and Uttara khand 44/39-44 , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Hamsapathyadi kashayam), Additional Information: -
(3) Medicine Name: Panchakola Churna, Reference: Sharangdhara Samhita Madhyam Khand 6/13-14, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Weeks, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: None
(4) Medicine Name: Varunadi Ghritam, Reference: Ashtanga Hrudaya Sutrasthana 15/21-22, Route: Oral, Dosage Form: Ghrita, Dose: 300(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information:
3Intervention ArmDrugClassical(1) Medicine Name: Trivrutta avaleham, Reference: Charak Kalpa Sthana 7/5-11, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 100(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Triphala Kwath), Additional Information: None
4Intervention ArmDrugClassical(1) Medicine Name: Triphala, Reference: Bhaishajya Ratnavali Shotha Rogadhikara 10, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -
5Intervention ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Charak Samhita Sutrasthana 5/93, Procedure details: The procedure of massaging the whole body below neck in a direction opposite to the orientation of hair with some pressure is called Udvartanam)
(1) Medicine Name: Kolakulathadi Churna, Reference: Charak Samhita Sutrasthana 3/18, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1000(g), Frequency: od, Duration: 1 Weeks
6Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushrut Samhita Chikitsasthana Chapter 33, Procedure details: Virechana is therapeutic purgation through the administration of herbal laxatives or purgatives after snehana and swedana procedures.)
(1) Medicine Name: Trivrutta avaleham, Reference: Charak Kalpasthana 7/5-11, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 100(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between 21 to 60 years of age of either sex.
2. Patients with the symptomatology of hypothyroidism and elevated TSH.
3. Hypothyroid patients with associated Dyslipidemias [13][14].
4. Patients willing to participate in the trial.
 
 
ExclusionCriteria 
Details  1. Conditions contraindicated for Snehana and Virechana Procedure.
2. Any other thyroid pathology or any other endocrine disorders like DM, PCOS, Hyperparathyroidism, etc.
3. Pregnant females and breastfeeding mothers.
4. Any other major systemic illnesses like CAD, IHD, Arrhythmias, Vulvar Heart disease, CVA, Abnormal BP, Aortic Aneurysm, etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Part 1-

Improvement in TSH level correction (Assumed value of TSH i.e., 7mIU/L would decline to 5.5mIU/L after the intervention)

Part 2-
Positive computational outcomes of Hamsapathyadi kashayam’s stimulatory effects on THRα & THRβ.
 		 To be assessed thrice at 0th, 49th, 98th day  
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in clinical features of hypothyroidism.
2. Improvement in lipid profile in Hypothyroidism-mediated dyslipidemias through-
HDL lower than 40 mg/dL
TC more than 200 mg/dL
TG more than 140 mg/dL
TC/HDL more than 05
3. Improvement in Apo-B levels hence lowering risk factors for atherosclerotic changes and CVS accidents.
4. Assessment of QOL of hypothyroid patients.
 		 Lipid profile- To be assessed thrice at 0th, 49th, 98th day
apolipo-B- To be assessed thrice at 0th, 49th, 98th day
QOL assessment- To be assessed thrice at 0th, 49th, 98th day  
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
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 - NO
Brief Summary  

BACKGROUND

§  Hypothyroidism affects approximately 11% of India’s population, with coastal areas experiencing a slightly higher prevalence compared to inland cities, and females being more affected than males.

§  The condition leads to various long-term complications such as dyslipidemia, atherosclerosis, depression, and increased cardiovascular disease risk.

§  Ayurveda lacks a direct analogy for hypothyroidism, but the concept of Anukta vyadhi helps in understanding its nature, manifestations, and causative factors.

§  An in-silico study has been conducted to investigate the effects of Hamsapathyadi Kashayam on thyroid receptors (THRα & THRβ), offering deeper insights into its potential mechanisms of action.

§  This approach aims to enhance our understanding of how Hamsapathyadi Kashayam could improve thyroid function and lipid metabolism disruption at a cellular level, providing safer and more effective treatment options.

 

OBJECTIVES OF THE RESEARCH PROJECT

Part1- Clinical Study

Part2- In-silico Study

The present study has been undertaken with the following objectives: -

 

PRIMARY OBJECTIVES-

PART 1- To evaluate the efficacy of Virechana followed by Hamsapathyadi Kashayam and Kanchanara Guggulu in Hypothyroidism.

PART 2- To do in-silico molecular docking of active components of Hamsapathyadi Kashayam against  target receptors THRα & THRβ.

 

SECONDARY OBJECTIVES-

1.     To reduce Apo-B levels in hypothyroidism and associated dyslipidemias and risk factors of atherosclerotic changes due to atypical lipid profile.

2.     To assess thyroid-specific ThyPRO-39 questionnaire in hypothyroid patients.

 

INVESTIGATIONS-

Investigations

Levels of assessment

TSH

to be assessed thrice at 0th, 49th, 98th day

Lipid profile

to be assessed thrice at 0th, 49th, 98th day

Apo-B

to be assessed thrice at 0th, 49th, 98th day

CBC with ESR

to be assessed once at 0th day

RBS

to be assessed once at 0th day

 

STUDY OUTCOMES-

PRIMARY OUTCOME-

Part 1- Improvement in TSH level correction (Assumed value of TSH i.e., 7mIU/L would decline to 5.5mIU/L after the intervention)

Part 2- Positive computational outcomes of Hamsapathyadi kashayam’s stimulatory effects on THRα & THRβ.

 

SECONDARY OUTCOME-

1.         Improvement in clinical features of hypothyroidism.

2.         Improvement in lipid profile in Hypothyroidism-mediated dyslipidemias through-

               HDL < 40 mg/dL

               TC > 200 mg/dL

               TG > 140 mg/dL

               TC/HDL > 05

3.         Improvement in Apo-B levels hence lowering risk factors for atherosclerotic changes and CVS accidents.

4.         Assessment of QOL of hypothyroid patients.

 

 
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