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CTRI Number  CTRI/2022/10/046718 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical assessment of chausathaprahari pippali and nirgundi taila pratimarsha nasya in hypothyroidism 
Scientific Title of Study   A clinical evaluation of chausathaprahari pippali and nirgundi taila pratimarsha nasya in the management of Hypothyroidism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Gautam 
Designation  PG Scholar 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8429766099  
Fax    
Email  anjaligautam351@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Meera Antiwal 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451586325  
Fax    
Email  antiwalmeera@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meera Antiwal 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451586325  
Fax    
Email  antiwalmeera@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi 
 
Primary Sponsor  
Name  Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi 
Type of Sponsor  Government medical college 
 
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 Anjali Gautam  Sir Sunderlal Hospital  OPD No.21 & OPD No.22 Kayachikitsa OPD Sir Sundarlal Hospital Institute of Medical Sciences Indian Medicine wing Banaras Hindu University
Varanasi
UTTAR PRADESH 		 8429766099

anjaligautam351@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sir Sunderlal Hospital  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: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-LevothyroxineLevothyroxine, Dose-1.6 microgm/kg wt for 3 months with monthly follow-up at every month.
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Bhaishajya ratnavali, Procedure details: 2 drops per nostril BD)
(1) Medicine Name: Nirgundi Taila, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 3 Months
(2) Medicine Name: Chausathprahari Pippali, Reference: Siddha Yoga Sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  (a)On the basis of symptoms and sign described for Hypothyroidism (without any complication) and TSH, T3, T4 level.
(b)Patients between age group of 20 to 60 years in either sex.
(c)Diagnosis and confirmed cases of Hypothyroidism. TSH level more than 5 -20 miul on two consecutive blood test.
(d)Patient not taking any other medicine for this disease. 
 
ExclusionCriteria 
Details  (a)Age below 20 yr and above 60 yr.
(b)Patient suffering from pituitary/ hypothalamic disorder or other non thyroidal illness.
(c)Patient taking any other medicine for this disease.
(d)Patient suffering from Diabetes mellitus, Cancer, Renal failure, IHD.
(e)Patient with obvious or suspected poor compliance.
(f)Pregnant woman, lactating woman, etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in various components of objective parameters and investigatory parameters.
Improvement in subjective features like tiredness,weakness,dry skin,cold intolerance,hair loss,weight gain,menstrual disturbances etc.
 		 3 months with 2 follow ups at every month
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in objective parameters
1)BMI
2)Weight in kgs
3)Waist-Hip Ratio
4)Hematological study
-Thyroid Profile
 		 3 months with 2 follow ups at every months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 
Date of First Enrollment (India)   25/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   70 cases of Hypothyroidism will be included in the interventional study which will be randomly distributed into two groups each comprising 35 patients. 
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