| CTRI Number |
CTRI/2023/05/052301 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Hypertension through Ayurveda |
|
Scientific Title of Study
|
Randomized clinical study to evaluate the efficacy of Shuddh Shilajit and Maansyadi Kashaya in the management of Aavrit Vyan w.s.r. to Essential Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rishabh |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan road, Karolbagh
New Delhi - 110005
India
Central
DELHI
110005
India |
| Phone |
9990300944 |
| Fax |
|
| Email |
rishabhkumar747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
HOD, Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan roas, Karolbagh
New Delhi - 110005
India
Central
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
HOD, Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol bagh
New Delhi - 110005
India
Central
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, Karol bagh, New Delhi-110005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishabh |
Ayurvedic and Unani Tibbia College and Hospital |
Ayurvedic and Unani Tibbia College and Hospital, Karol bagh
Central
DELHI |
9990300944
rishabhkumar747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Ayurvedic and Unani Tibbia College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: AVRUTA-VATAH/AVARANAVATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shuddh Shilajit , Reference: Rastantra sar and Siddhaprayoga Sangrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Decoction of Krishna Sariva and Yashtimadhu ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Maansyadi Kashaya, Reference: Siddha yog Sangrah, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shuddha Shilajit and Maansyadi kashaya , Reference: Rastantra sar and siddhaprayog sangrah, siddhayog sangrah , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: decoction of krisna sariva and yashtimadhu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject willing to participate and able to provide written informed consent.
2. Patient diagnosed as stage-I Essential Hypertension would be selected for study on the basis of 8th JNC & WHO criteria.
3. Subjects who are able to come for follow up on fixed visits. |
|
| ExclusionCriteria |
| Details |
1. Already diagnosed cases of Cardiovascular disease/ Cerebrovascular disease/ Renal disease/ Hypertensive Retinopathy.
2. Subjects with any unstable heart disease or known cases of MI, unstable angina or CHF.
3. Patients with concurrent hepatic dysfunction (defined as AST and/or ALT >2times of the upper normal limit) or Renal dysfunction, uncontrolled pulmonary dysfunction (asthmatic and COPD subjects).
4. Subjects with current or past malignancy.
5. Subject of have recent history or who are currently known to abuse of alcohol or drugs.
6. Subjects suffering from major systemic illness neccessitating long term drug treatment(rheumatoid arthritis, psyco-neuro-endocrinal disorders, Tb, AIDS).
7. Pregnant/lactating women.
8. Subject on systemic or local steroids, oral contraceptive pills or estrogen replacement therapy.
9. Subjects having hypersensitivity to any of the trial drug.
10. Subjects who have completed participation in any other clinical trial during the past six (06) months. |
|
|
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 |
| Improvement in Subjective symptoms |
Follow up at 15 days interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Blood Pressure readings |
Follow up at 15 days interval |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction Hypertension or elevated blood pressure is a serious medical condition that significantly increases the risk of heart attack, stroke, kidney failure, and blindness. it is also called silent killer because most of the suffers (85%) are asymptomatic and as per available reports, in more than 95% cases of hypertension underlying cause is unknown. such patients have essential hypertension. WHO had published "A Global Brief on Hypertension- silent killer, a public health crisis" on World health day 2013.
Research Question Whether Shuddh Shilajit and Maansyadi Kashaya effective in the management of essential hypertension?
Material and Methods The study design is as follows: Study type - Interventional Subtype - Comparative Clinical trial Purpose - Treatment timing - prospective Masking - Open clinical Sampling method - Simple random End point - Efficacy and Safety Sample size - 60 patients No. of Groups - 3 Selection of patients - OPD/IPD of Ayurvedic and Unani Tibbia College and Hospital Sample population - Subjects from Ayurvedic and Unani Tibbia College and Hospital Duration of Trial - 3 months |