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CTRI Number  CTRI/2023/09/057414 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 29/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the added effect of emetic therapy followed by kanchanara kashaya avapeedaka nasal medication  
Scientific Title of Study   A Comparitive Clinical Study To Evaluate The Added Effect Of Vamana Karma Along With Kanchanara Twak Kashaya Avapeedaka Nasya 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  Dr Swathi N 
Designation  PG Scholar 
Affiliation  Government ayurvedic medical college bangalore  
Address  Second year pg scholar department of panchakarma Government ayurvedic medical college Bangalore dhanwantari road

Bangalore
KARNATAKA
560009
India 
Phone  7338483883  
Fax    
Email  swathicrs38@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ananta S Desai 
Designation  Professor and head of the department  
Affiliation  Government ayurvedic medical college bangalore  
Address  Department of panchakarma government ayurvedic medical college dhanwantari Road bangalore 560009

Bangalore
KARNATAKA
560009
India 
Phone  9448185896  
Fax    
Email  anantdesai30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ananta S Desai 
Designation  Professor and head of the department  
Affiliation  Government ayurvedic medical college bangalore  
Address  Department of panchakarma government ayurvedic medical college dhanwantari Road bangalore 560009

Bangalore
KARNATAKA
560009
India 
Phone  9448185896  
Fax    
Email  anantdesai30@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Swathi N 
Address  Government ayurvedic medical college bangalore dhanwantari Road 560009 
Type of Sponsor  Other [Self] 
 
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 
Swathi N  Sri Jayachamarajendra Government ayurvedic and unani hospital bangalore   OPD number 6ABC Department of panchakarma sri jayachamarajendra government ayurvedic and unani hospital Dhanwantari Road majestic 560009
Bangalore
KARNATAKA 		 7338483883

swathicrs38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee GAMC Bangalore  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: GALAGANDAH (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam, नस्यम् (Procedure Reference: Charaka samhita, Procedure details: 1)Poorva kara Mukha abhyanga with murchita tila taila followed by pata sweda 2) pradhana karma Kanchanara kashaya avapeedaka nasya 6 bindu each nostrils 3)paschat karma Dhoomapana with haridra varthi )
(1) Medicine Name: Murchita tila taila, Reference: Baishajya ratnavali , Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: Kanchanara kashaya, Reference: Baishajya ratnavali , Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 6(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-vamanakarma, वमनकर्म (Procedure Reference: Charaka samhita , Procedure details: Poorva karma Deepana pachana with chitarkadi vati Snehapana with varunadi gritha Abhyanga with murchita tila taila followed by usna jala snana Pradhanakarma Vamana with madanaplapippali yoga Pashat karma Dhoomapana with haridra varti Samsarjana krama Followed by Poorva karma Mukha abhyanga with murchita tila taila followed by pata sweda Pradhana karma Kanchanara kashaya avapeedaka nasya 6 bindu to each nostrils Paschat karma Dhoomapana with haridra varti )
(1) Medicine Name: Chitrakadi vati, Reference: Charaka samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 3 Days
(2) Medicine Name: Varunadi gritha, Reference: Astanga hrudaya, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days
(3) Medicine Name: Murchita tila taila, Reference: Baishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days
(4) Medicine Name: Madanaphala pippali yoga, Reference: Charaka samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 1 Days
(5) Medicine Name: Kanchanara kashaya , Reference: Baishajya ratnavali , Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 3(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with Hypothyroidism.
Subjects fit for Vamana karma & Nasya karma.
Subjects between 18 yrs and 56 yrs of age of both genders.  
 
ExclusionCriteria 
Details  Subjects associated with uncontrolled Diabetes Mellitus, Hypertension,Congenital anomalies
Carcinomas of the thyroid gland and Cardiac ailments
2. Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in
Constipation
Loss of appetite
Dryness of skin
Fatigue 		 Before treatment On 0th day
After treatment on 42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
Thyroid profile
BMI 		 Before treatment 0th day
After treatment 42nd day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/09/2023 
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 Yet Recruiting 
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   In the present era due to changes in the life style, metabolic diseases are increasing drastically.Hypothyroidism is a endocrinal hypometabolic condition in which there will be low T3 T4 hormone and high TSH levels in blood leading to signs and symptoms like weight gain irregular menstruation constipation loss of appetite etc.Vamana followed by nasya helps in correcting the metabolism of the body thus correcting hypothyroidism. In this study vamana followed by kanchanara kashaya avapeedaka nasya is done to evaluate the added effect of vamana along with nasya in hypothyroidism.  
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