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CTRI Number  CTRI/2024/11/076518 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A COMPARATIVE CLINICAL STUDY TO KNOW THE EFFECT OF EMESIS THERAPY USING EMETIC NUT PROCESSED WITH DIFFERENT DRUGS WITH ITS PHYTOCHEMICAL ANALYSIS IN HYPOTHYROIDISM  
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY ON VAMANA KARMA USING MADANAPHALA PIPPALI PROCESSED WITH DIFFERENT BHAVANA DRAVYAS WITH ITS PHYTOCHEMICAL ANALYSIS 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 SHAKUNTALA S P 
Designation  ASSISTANT PROFESSOR  
Affiliation  GOVERNMENT AYURVEDA MEDICAL COLLEGE BENGALURU 
Address  GOVERMNENT AYURVEDA MEDICAL COLLEGE BANGALORE DHANVANATRI ROAD NEAR MEJESTIC 560009
DHANVANATRI ROAD NEAR MEJESTIC 560009
Bangalore
KARNATAKA
560009
India 
Phone  9742150215  
Fax    
Email  shakuboya123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Vidyashree Ashok Ghanti  
Designation  PG Scholar 
Affiliation  Government Ayurveda medical College Banglore  
Address  Government ayurveda medical College Bengaluru near dhanvantari road near majestic 560009

Bangalore
KARNATAKA
560009
India 
Phone  8970091914  
Fax    
Email  vidyadoc8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Vidyashree Ashok Ghanti  
Designation  PG Scholar 
Affiliation  Government Ayurveda medical College Banglore  
Address  Government Ayurveda medical College dhanvantari road near majestic Bengaluru Karnataka 560009

Bangalore
KARNATAKA
560009
India 
Phone  8970091914  
Fax    
Email  vidyadoc8@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT AYURVEDA MEDICAL COLLEGE BENGALURU 
 
Primary Sponsor  
Name  DR VIDYASHREE ASHOK GHANTI 
Address  GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE DHANVANATRI ROAD NEAR MEJESTIC 560009 
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 Vidyashree Ashok Ghanti  GOVERNMENT AYURVEDA MEDICAL COLLEGE BENGALURU  Department of Panchakarma, Out patient department room number 6, Dhanwantari road near M, Bengaluru 560009
Bangalore
KARNATAKA 
8970091914

vidyadoc8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee Government Ayurveda medical College Bengaluru   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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charaka samhita siddhisthana , Procedure details: Purva karma Collection & processing of Madanaphala 1 Madanaphala which are ripe, undamaged, not very green, of pale colour will be collected in between spring & summer season. •2 After cleaning, fruits will be wrapped in grass, smeared with cow dung & after drying will be stored in heap of husk of shali for eight days. 3 Thereafter, when they will be soft & develop good aroma like that of honey, they will be taken out & seeds will be separated. Further, Madanaphala pippali will be given bhavana with Dadhi, Madhu & Palala individually & in one group, bhavana will be given with all three in the same sequence. These processed Madanaphala pippali will be sent for phytochemical analysis of Randianin, Oleanolic acid, Glucoside RDG-1, Randialic acid, Oleic acid, Palmitic acid, Mannitol, Stearic acid, Lignoceric acid & Arachidic acid. Preparation of patient 1 Deepana Pachana with Chitrakadi vati 1 TID before food, till nirama lakshana. Snehapana with Moorchita tila taila till Samyak snigdha lakshana. Vishrama Kala- Abhyanga with Moorchita tila taila followed by ushnajala snana for one day. Kapha utkleshaka ahara sevana Pradhana karma Group A- Vamana with Dadhi bhavita Madanaphala pippali Group B- Vamana with Madhu bhavita Madanaphala pippali Group C- Vamana with Palala bhavita Madanaphala pippali Group D- Vamana with Dadhi, Madhu & Palala bhavita Madanaphala Pippal Paschat karma 1 Dhoomapana with Haridra varti 2 Samsarjana krama depending on Shuddhi )
2Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charaka samhita siddhisthana , Procedure details: One day after samyak snehana)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Subjects diagnosed with Hypothyroidism who are with raised TSH levels.
2 Subjects fit for Vamana karma.
3 Subjects aged between 20-60 years irrespective of sex.
 
 
ExclusionCriteria 
Details  1 Subjects with uncontrolled Diabetes Mellitus, Hypertension, Cardiac disease, Congenital anomalies
and Carcinoma of the thyroid gland, which may interfere with the treatment.
2 Pregnancy and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
After treatment, expected to bring raised TSH to normal TSH level and relief from symptoms  Both subjective and objective parameters except thyroid profile will be assessed and compared on
Before treatment On 0th day
After completion of the treatment On 16th day
Follow up On 45th day

Thyroid profile will be assessed before treatment (D-0) and after treatment (D-45).
 
 
Secondary Outcome  
Outcome  TimePoints 
To enhance the quality of life by reducing the sufferings in the patient   Both subjective & objective parameters except thyroid profile will be assessed & compared on
Before treatment On 0th day

After completion of the treatment On 16th day
Follow up On 45th day

Thyroid profile will be assessed before treatment (D-0) & after treatment (D-45).
 
 
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)   15/11/2024 
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="6"
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  

Samshodhana is the purificatory measure of eliminating morbid doshas from the body and cure the disease from its root cause, hence prevents its recurrence. Vamana karma is one among the effective purificatory therapy and the prime modality of treatment mentioned for Kaphaja disorders by which vitiated doshas are expelled out through mukhamarga. In classics larger number of formulations are described for the Vamana karma, among them Madanaphala is said to be the best because of its anapayitva guna.  Ideal medicine is the one which is given in alpamatra, induces mahavega, which is bahudoshahara, sukhashodhaka, laghupaka, sukhaswada and vyadhinashaka. Apart from matra and anupana the efficacy of drug also depends on proper collection of the drug during appropriate season and time, processing and storage. With an appropriate samskara even a small quantity of drug may produce better effect. Bhavana is one among such samskara which is told under the processing of Madanaphala.

 

                          Bhavana samskara enhances the potency of the drug by imbibing the qualities of bhavana dravya. In classics different bhavana dravyas have been mentioned for processing of Madanaphala.  Acharya Charaka and Vagbhata have mentioned the use of Ghrita, Dadhi, Madhu and Palala as bhavana dravyas, whereas Acharya Sushruta mentioned only three bhavana dravyas namely Dadhi, Madhu and Palala. Here, quality of the drug can be assured by proper collection of drug and potency by classical processing method. Quality and potency of herbal drug is the need of present day in order to confirm its therapeutic value.

    

                          Vamana karma is indicated in many of the Kaphaja vyadhis, one among them is   Galaganda. In Galaganda, vata and kapha together with meda getting localized in the gala pradesha produces swelling. Kaphaja galaganda can be considered similar to Hypothyroidism. It is one of the common endocrine disorder resulting from deficiency of thyroid hormone. The prevalence of Hypothyroidism in the overall population is 10.95% of which 3.47% were previously undetected and 7.48% were self-reported case. Prevalence increases with age and is higher in females than in males. General features are weight gain, dry skin, constipation, intolerance to cold, fatigue, loss of hair. Untreated hypothyroidism can contribute to hypertension, dyslipidemia, infertility, cognitive impairment and neuromuscular dysfunction. Hormonal replacement therapy is the line of treatment in contemporary science which has adverse effects like mood swings, heat sensitivity, edema of hands, feet and ankle. Studies have shown the effectiveness of Vamana karma in the management of Hypothyroidism.

                    

                           There are many studies conducted on Vamana karma with Madanaphala but none of the studies have been done on individual bhavana dravya. As the potency of the drug will get increase by proper bhavana, this study is selected to see the efficacy of individual and combined effect of bhavana dravyas along with its phytochemical analysis. Hypothyroidism has been selected in the present study as it is indicated for Vamana karma. Here Moorchita tila taila for snehapana and abhyanga is selected based on the involvement of dosha. Hence the study with title “A comparative clinical study on Vamana karma using Madanaphala pippali processed with different bhavana dravyas with it’s phytochemical analysis in Hypothyroidism” is planned to develop some evidence in this regard.

           

 
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