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CTRI Number  CTRI/2023/02/050086 [Registered on: 26/02/2023] Trial Registered Prospectively
Last Modified On: 14/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of the efficacy of Gandamalakandan rasa and Kanchanar Guggulu along with tumbi taila nasya in the management of Hypothyroidism-A randomised comparative clinical study. 
Scientific Title of Study   A randomised comparative clinical study to evaluate the efficacy of Gandamalakandan rasa and Kanchanar Guggulu along with Tumbi taila 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  Dr Kanchan Gajare 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD No 7 Ground floor, Hospital Block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 New Delhi DELHI 110076

New Delhi
DELHI
110076
India 
Phone  8595716491  
Fax    
Email  kanchangajare1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jonah S 
Designation  Professor and HOD 
Affiliation  All India Institute of Ayurveda 
Address  6th floor Acedemic block Department of Kayachikitsa All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi

New Delhi
DELHI
110076
India 
Phone  8589805246  
Fax    
Email  jonahdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanchan Gajare 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD No 7 Ground floor Hospital Block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 New Delhi DELHI 110076

New Delhi
DELHI
110076
India 
Phone  8595716491  
Fax    
Email  kanchangajare1996@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 
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 Kanchan Gajare  All India Institute of Ayurveda  Department of Kayachikitsa,C block, 6th floor
New Delhi
DELHI 		 8595716491

kanchangajare1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: MEDOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gandamalakandan Rasa, Reference: Basavarajeeyam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Kanchanar Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang Hridaya, Procedure details: Position of the patient: Supine 1.Sthanik Snehan Swedana followed by instillation of 6 Bindu(1 Bindu = 0.55ml Reference: Nagalakshmi B Vinaykumar KN. A Study on standardization of Bindu Pramana in Nasya Karma Vol 5 Issue 3 JAIMS Charaka Publications May-June 2020) of Tumbi Taila in each nostril alternately. Patient should remain in the supine position for 1.5 minute after instillation of nasya. Kaval (gargles) with koshna jala.)
(1) Medicine Name: Tumbi taila, Reference: Chakradutta, Route: Nasal, Dosage Form: Taila, Dose: 3.3(ml), Frequency: od, Duration: 14 Days
4Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang Hridaya, Procedure details: Position of the patient: Supine 1.Sthanik Snehan Swedana followed by instillation of 6 Bindu(1 Bindu = 0.55ml Reference: Nagalakshmi B Vinaykumar KN. A Study on standardization of Bindu Pramana in Nasya Karma Vol 5 Issue 3 JAIMS Charaka Publications May-June 2020) of Tumbi Taila in each nostril alternately. Patient should remain in the supine position for 1.5 minute after instillation of nasya. Kaval (gargles) with koshna jala.)
(1) Medicine Name: Tumbi taila, Reference: Chakradutta, Route: Nasal, Dosage Form: Taila, Dose: 3.3(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.TSH levels from 5.6mIU/L to 19.9mIU/L
2.Patients having signs and symptoms of Hypothyroidism 1)weight gain 2)cold intolerance 3)fatigue 4)dry skin 5)dry hair 6)menorrhagia 7)constipation 8)hoarseness of
voice 9)alopecia 10)aches and pains 11)muscle stiffness 12)deafness 13)depression 14)infertility 15)psychosis 16)periorbital edema 17)anaemia 18)bradycardia 19)hypertension
3.Nasya Arha (Patients suitable for Nasya) 
 
ExclusionCriteria 
Details  1.Patients having TSH level greater than 19.9mIU/L
2.Recent thyroid surgery (within 12 months)
3.Patients suffering from diseases like
1)HIV 2)TB 3)Encephalopathy 4)Goiter 5)Other endocrine
disorders and other autoimmune disorders 6)Lactating and pregnant women 7)Uncontrolled Diabetes Mellitus 8)uncontrolled Hypertension
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OUTCOME

Improvement in the signs and symptoms of hypothyroidism.
(after 4 weeks and 8 weeks)  		 (DAY-0) (DAY-29) (DAY-57)
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life in Hypothyroidism patients.
 		 (DAY-29) (DAY-57) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary                                                      Need of the Study
                     Prevalence of hypothyroidism in India is 10%.The prevalence ratio of male:female is 1:6. Thyroid hormone is required for the normal functioning of each and every tissue of the body. Hence, its deficiency manifests as multisystem involvement. The only treatment available in modern medicine is in the form of synthetic hormone Levothyroxine. Even after years of treatment,it is associated with the failure to provide relief in clinical manifestations.Moreover ,excessive thyroid replacement carries the 2 7 potential for serious long term metabolic complications (e.g., accelerated osteoporosis). Thyroid hormone increases bone mineral resorption.The net effect of excessive thyroid hormone is increased bone resorption and a subsequent decrease in bone density i.e.osteoporosis. Looking to the pathogenesis and complications of hypothyroidism, it requires a systemic and radicle therapy for which Ayurveda may provide a ray of hope through its holistic approach.
 
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