| 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 |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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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
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Scientific Title of Study
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A COMPARATIVE CLINICAL STUDY ON VAMANA KARMA USING MADANAPHALA PIPPALI PROCESSED WITH DIFFERENT BHAVANA DRAVYAS WITH ITS PHYTOCHEMICAL ANALYSIS IN HYPOTHYROIDISM
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
|
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Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA MEDICAL COLLEGE BENGALURU |
|
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Primary Sponsor
|
| Name |
DR VIDYASHREE ASHOK GHANTI |
| Address |
GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE
DHANVANATRI ROAD NEAR MEJESTIC 560009 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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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 |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee Government Ayurveda medical College Bengaluru |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (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
)
| | 2 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (Procedure Reference: Charaka samhita siddhisthana , Procedure details: One day after samyak snehana)
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Inclusion Criteria
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| 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.
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| 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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| 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).
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Secondary Outcome
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| 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).
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Target Sample Size
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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 |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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. |