| CTRI Number |
CTRI/2025/01/079134 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Treatment for Metabolic Syndrome by Panchakarma Therapy (Virechana) and Ayurvedic Medicine |
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Scientific Title of Study
|
Comparative clinical trial to Evaluate the efficacy of Phalatrikadi Ghanvati with and without Virechana Karma in Metabolic Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital, karol bagh New Delhi 110005 |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia college and hospital, Karol Bagh Ajmal Khan Road, New Delhi 110005
Central
DELHI
110005
India |
| Phone |
09467797705 |
| Fax |
|
| Email |
ritusahrawat123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Jindal |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital, Karol Bagh, New Delhi -110005 |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia college and hospital, Karol Bagh Ajmal Khan Road, New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9811765501 |
| Fax |
|
| Email |
nitjin2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritu |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital, karol bagh New Delhi 110005 |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia college and hospital, Karol Bagh Ajmal Khan Road, New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9467797705 |
| Fax |
|
| Email |
ritusahrawat123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Ayurvedic and Unani Tibbia college and hospital, Karol Bagh Ajmal Khan Road, New Delhi 110005
|
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia college and hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia college and hospital, Karol Bagh Ajmal Khan Road, New Delhi 110005
|
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu |
Ayurvedic and Unani Tibbia College and Hospital |
OPD No. 2,Department of Panchakarma ,Ajmal Khan Road Block 56, Karol Bagh New Delhi 110005
Central
DELHI |
9467797705
ritusahrawat123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Agnivesha . Charaka, Dridhabala, CharakaSamhita Part II, ChikitsaSthana, Prameha Chikitsa Adhyaya, 6/15. Charaka Samhita. chaukhamba publication; 2017 , Procedure details: Pachana will be done using trikatu churna followed by snehapana using Panchatikta ghrit. Then, sarvanga abhyanga (using tila taila) & sarvanga swedana (vashp sweda ). Virechana karma will then be performed using trivrit avleha with anupan of triphala kwath followed by samsarjana krama for 3 or 5 or 7 days as per the virechana karma shuddhi. Followed by intake of phalatrikadi ghanvati upto 75th day of study. )
(1) Medicine Name: Phalatrikadi Ghanvati, Reference: Agnivesha . Charaka, Dridhabala, CharakaSamhita Part II, ChikitsaSthana, Prameha Chikitsa Adhyaya, 6/26. Charaka Samhita. chaukhamba publication; 2017 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 75 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phalatrikadi Ghanvati, Reference: Agnivesha . Charaka, Dridhabala, CharakaSamhita Part II, ChikitsaSthana, Prameha Chikitsa Adhyaya, 6/26. Charaka Samhita. chaukhamba publication; 2017 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex of age group 20 to 60 years.
2. Patient fulfilling more than or equal to 3 out of 5 criteria for MetS (according to NCEP ATP III criteria):-
I. Abdominal obesity (waist circumference more than 102 cm (40 inches) in men
or 88cm (35 inches) in women.
II. Serum triglycerides level more than 150mg/dl.
III. Low HDL Cholesterol less than 40mg/dl and less than 50mg/dl for men and women,respectively.
IV. Blood pressure more than or equal to 130 mmHg systolic or more than or equal to 85 mmHg diastolic.
V. Fasting Plasma Glucose level more than 100mg/dl
3. Patient who are considered fit for virechana procedure for group A.
4. Patients willing to give written consent. |
|
| ExclusionCriteria |
| Details |
Any patients on treatment for Diabetes mellitus, Dyslipidaemia and Hypertension.
2. Patients who present with blood pressure in the following range. systolic more than or equal to 180 mmHg or diastolic more than or equal to 120 mmHg.
3. Patients having Hba1c more than 7
4. Subject having systemic illness, malignancy, major endocrine disorders will be excluded from this study.
5. Know case of IHD, CAD, CCF or other major cardiovascular problems will not be included for this study.
6. Patients with renal (Sr. creatinine more than 1.8mg/dl) OR hepatic impairment SGOT, SGPT
and GGT more than five times than normal value.
7. Patients on anti-retroviral, anti-tubercular and antibiotic medications.
8. Pregnant and lactating women will not be included.
9. Patients requiring emergency treatment.
10. For group A : Patients who are contraindicated for virechana karma- like lower GI
bleeding, prolapse of rectum, incontinence of stool will not be included. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients showing improvement in parameters of extended lipid profile,blood sugar level, blood pressure, waist circumference and BMI after use of phalatrikadi ghanvati with and without virechana karma. |
Group A- Baseline,after Virechana karma, Day 15, Day 30, Day 45,Day 60,Day 75
Group B - Baseline,day 15,day 30,day 45,day 60,day 75
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The proportion of patients showing changes in the serum adiponectine after use of
phalatrikadi ghanvati with & without virechana karma. |
Group A & Group B -Baseline,Day 75 |
|
|
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)
|
01/02/2025 |
| 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 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
|
Metabolic syndrome encompasses a combination of interconnected physiological, biochemical, clinical and metabolic factors that significantly elevate the risk of cardiovascular diseases, type 2 diabetes mellitus and all cause mortality. It is an emerging clinical challenge in the society today. A fat rich diet, sedentary lifestyle, stress, sleep disturbances, excessive alcohol use, being overweight, genetic factors can contribute to the metabolic syndrome. In Ayurveda, the initial stage of Metabolic syndrome can be correlated with Medavaha Sroto Dushti (vitiation of micro channels of lipid metabolism and transportation), which manifests as a group of symptoms of Atisthula(obesity) and premonitory signs and symptoms of Prameha. Clinical features of Metabolic syndrome like Atitrushna, Daurgandhya, Swedadhikya resemble with Apathya Nimittaja Prameha mentioned in ayurveda. In contemporary science, the approach of management is multifaceted involving lifestyle intervention and use of drugs like-hypolipidemic, anti-diabetic and anti-hypertensive. However, these approaches of modern therapy have several long-term & short term side effects. So, there is a need for urgent development of effective and safe approaches for preventing and managing the syndrome. Majority of achayaras has told samshodhan chikitsa as prime treatment for shtula pramehi. So, here I taken virechana as a therapeutic measure because it will improve the function of digestive system through the way of intensive purgation. It clears the microcirculatory channels which results in better metabolites and blood circulation which result in the improved efficacy of liver. As it reduces the extra unnecessary burden on liver which result in correcting the physiology of liver and hence the reduces the production of excess lipids. The major pathway of excretion of excess cholesterol from the body is usually by conversion to bile acids excreted in faeces as bile salts and virechana increases this secretion and causes purgation. And also phalatrikadi ghanvati has been told a prime shamana aushadh in sarva prakara prameha and it has Medohara, Pramehahara, Rasayana, Deepana, Pachana properties. So, the goal of current study is to assess the effect of phalatrikadi ghanvati used with and without virechana karma in managing metabolic syndrome. According to reports, patients of metabolic syndrome had considerably low serum adiponectine level than healthy controls. So, in this study we will also see the effect of phalatrikadi ghanvati with and without virechana karma on serum adiponectine in patients of metabolic syndrome. |