| CTRI Number |
CTRI/2025/05/087732 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of participation in interventation of metabolic syndrome |
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Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF HERBAL COMPOUND WITH AND WITHOUT VIRECHAN KARMA IN CASES OF DHATWAGNIMANDYA (W.S.R.TO METABOLIC SYNDROME) |
| Trial Acronym |
NIL |
|
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 |
Shahnuma Ansari |
| Designation |
Research Scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital ,Tulsidas Marg ,Tudiyaganj,Lucknow,226004 Uttar Pradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
07991756506 |
| Fax |
|
| Email |
ansarishahnumaansari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anant Krishna |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital ,Tulsidas Marg ,Tudiyaganj,Lucknow,226004 Uttar Pradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9452274856 |
| Fax |
|
| Email |
anant10patel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shahnuma Ansari |
| Designation |
Research Scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital ,Tulsidas Marg ,Tudiyaganj,Lucknow,226004 Uttar Pradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
07991756506 |
| Fax |
|
| Email |
ansarishahnumaansari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow, Uttar pradesh,226004 |
|
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Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow, Uttar pradesh,226004 |
| 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 |
| Shahnuma Ansari |
State Ayurvedic College and Hospital Lucknow |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital ,Tulsidas Marg ,Tudiyaganj,Lucknow,226004 Uttar Pradesh India
Lucknow
UTTAR PRADESH |
07991756506
ansarishahnumaansari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAC INSTITUTIONAL ETHICS COMMITTE |
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:E748||Other specified disorders of carbohydrate metabolism. Ayurveda Condition: MANDAGNIH/ AGNISADA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kalingaadi kwath ghan vati and kiratiktaadi kwath ghan vati, Reference: charak chikitsa 2/200and 2/202, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Group A- patients will be treated with herbal coumpound 2 vati(250mg each ) for three months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kalingaadi kwath ghan vati and kiratiktaadi kwath ghan vati, , Reference: charak chikitsa 2/200and 2/202,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Group A- patients will be treated with herbal coumpound 2 vati(250mg each ) for three months
Group B- patients of this group will be treated with herbal compound 2 vati (250mg each) after three days of virechan karma with 2 vati ofIchhabhedi ras |
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1. Age- 21- 60 years
2. Fasting glucose 100 mg/dl- 140mg/dl
3. Blood Pressure 130/90 mm Hg-150/110mmHg
4. HDL 40mg/ dl -50mg/dl
5. Waist circumferance 90cm-110cm in men
80cm-100cm in women
6. BMI 25-40
7. Triglyceride 150mg /dl-200mg/dl
8. Patient having all essential criteria and minimum 50%nonessential criteria must be present
for selection of cases
9. In the patients minimum 50% objective parameter must be present for selection of cases |
|
| ExclusionCriteria |
| Details |
Exclusion criteria |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Objective Parameter
1. Abdominal Obesity
2. BMI above 25
3. High Triglycerides
4. Low HDL cholesterol
5. High Blood pressure or using to lower blood pressure.
6. High fasting blood glucose
7. Increased blood clotting tendency
8. Insulin resistance.
9. High VLDL and VLDL level
In the patients minimum 50% objective parameter must be present for selection of cases. |
before trial,0day,1th month,2 month, 3 month after trial. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Subjective parameter
essential criteria
1.Snigdhaangata(smoothness)
2.Udaraoarshvavriddhi (abdominal obesity)
3.Daurgandhya(foul smell from body)
noneseeential criteria
1.Hridyautkleda(heaviness in chest)
2.Prasake(salivation)
3.Kasa(cough)
4.Shwas(breathlessness)
patient having all essential criteria and 50% nonessential criteria must be present for selection of cases. |
before trial,0day,1th month,2 month, 3 month after trial. |
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="5"
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
|
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Brief Summary
|
The Present Synopsis Entitled "A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF HERBAL COMPOUND WITH AND WITHOUT VIRECHAN KARMA IN CASES OF DHATWAGNIMANDYA (W.S.R.TO METABOLIC SYNDROME)"
Aim : 1. To evaluate the clinical efficacy of herbal compound. 2. To evaluate the clinical efficacy of herbal compound after Virechana karma. Objective: 1. To observe the disease Dhatwagnimandya clinically during the follow up period with and without the procedure. 2. To access the effectiveness of probable mode of action of herbal compound with and without virechan karma. Plan of Study For purpose of clinical trial, the patient of Dhatwagnimandya will be selected regardless of sex, religion ,socioeconomic status and occupation in the age group of 21-60 years from OPD/IPD of State Ayurvedic college &Hospital, Lucknow and also the referred cases which fullfil the criteria. After clinical examination ,history and lab investigation patients fulfilling the inclusion criteria and exclusion criteria will be enrolled for the clinical trial Type of Study- Randomized parallel group study Period of Study- Total duration of clinical trial will be of 3 months. Follow up period without drug of Procedure- Follow up of all registered patients will be of one month without giving herbal compound and virechan karma procedure to assess the condition of patients & to observe any side effect of procedure.
Inclusion criteria 1. Age- 21- 60 years 2. Fasting glucose 100 mg/dl- 140mg/dl 3. Blood Pressure 130/90 mm Hg-150/110mmHg 4. HDL 40mg/ dl -50mg/dl 5. Waist circumferance 90cm-110cm in men 80cm-100cm in women 6. BMI 25-40 7. Triglyceride 150mg /dl-200mg/dl 8. Patient having all essential criteria and minimum 50%nonessential criteria must be present for selection of cases 9. In the patients minimum 50% objective parameter must be present for selection of cases 10.Patient fit for virechan karma. Exclusion criteria 1. Age group <2l years and > 60 years of age 2 Uncontrolled Diabetes Mellitus (Type 2) 3. Uncontrolled Hypertension on or with complication. 4. Known case of Ischemic heart Disease Cardiac Heart failure and any other vascular disorder. 5. Aggravation of complaints. 6. Uncontrolled obesity with BMI >40 7. Patients develops any serious adverse effect (A necessitating hospitalization) 8. Any addiction of Tobacco & Alcohol 9. Pregnant Lady or lactating mother 10. unwilling Patient will be excluded.Grouping of patient Minimum 60 patients of age group 21-60 years will be divided into groups selected randomly for the clinical trial. Group A -Patients of this group will be treated with herbal compound 2 vati (250mg each) for 3 months Group B - Patients of this group will be treated with herbal compound 2 vati (250mg each) for 3 months after three days of virechan karma Diet Plan and Exercise protocol will be common both in two groups.
Critaria of selection of cases Patient will be enrolled for clinical trial in this study on the basis of clinical and biochemical lab findings as per follows. Clinical Criteria Subjective parameter Essential criteria 1.Snigdhaangta(smoothness) 2.Udaroarshva vriddhi(abdominal obesity) 3.Daurgandhya(foul smell fron body) Nonessential criteria 1.Hridyautkleda(heaviness in chest) 2.Praseka(salivation) 3.Kasa(cough0 4.Shwasa(breathlessness) Patient having allessential criteria and 50%nonessential criteria must be present for selection of cases. Objective Parameter 1. Abdominal Obesity 2. BMI above 25 3. High Triglycerides 4. Low HDL cholesterol 5. High Blood pressure or using to lower blood pressure. 6. High fasting blood glucose 7. Increased blood clotting tendency 8. Insulin resistance. 9. High VLDL and VLDL level In the patients minimum 50% objective parameter must be present for selection of cases.
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