| CTRI Number |
CTRI/2025/02/080034 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Role of Manasika Bhavas in etiopathogenesis of Raktachap and its management with Pushkar muladi churna |
|
Scientific Title of Study
|
The Role of Manasika Bhavas in etiopathogenesis of Uccharaktachapa (Essential Hypertension) and its management with Pushkar muladi churna and Shirodhara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Irfan Ahmad Quraishi |
| Designation |
P G Scholar |
| Affiliation |
S G M P G Ayurvedic college and hospital Saheri Ghazipur |
| Address |
Department of Rog Nidana, S G M P G Ayurvedic college and hospital Saheri
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9621569518 |
| Fax |
|
| Email |
dr.Irfan831@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad Kumar Gawali |
| Designation |
Professor |
| Affiliation |
S G M P G Ayurvedic college and hospital Saheri Ghazipur |
| Address |
Head of Department Rog Nidana, S G M P G Ayurvedic college and hospital Saheri
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9621569518 |
| Fax |
|
| Email |
drshyamlal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Irfan Ahmad Quraishi |
| Designation |
P G Scholar |
| Affiliation |
S G M P G Ayurvedic college and hospital Saheri Ghazipur |
| Address |
Department Of Rog Nidana, S G M P G Ayurvedic college and hospital Saheri
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9621569518 |
| Fax |
|
| Email |
dr.Irfan831@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rog nidana S G M P G Ayurvedic College and Hospital Saheri Ghazipur Uttar pradesh India 233302 |
|
|
Primary Sponsor
|
| Name |
Dr Mohd Irfan Ahmad Quraishi |
| Address |
S G M P G Ayurvedic college and hospital Saheri Ghazipur, Uttar Pradesh India 233302 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mohd Irfan Ahmad Quraishi |
S. G. M. P. G. Ayurvedic College and Hospital |
Department of Rog Nidana Saheri India 233302
Ghazipur
UTTAR PRADESH |
9621569518
dr.Irfan831@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC S.G.M.P.G. Ayurvedic College Saheri Ghazipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: pushkarmuladi churna, Reference: BR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Procedure | - | KSHIRDHARA | (Procedure Reference: BR, Procedure details: Kshiradhara will be performed for 45 minutes for the duration of 21 days to all the patients with proper Purva and Pashchat karma of Shirodhara )
(1) Medicine Name: Pushkarmuladi churna, Reference: BR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Criteria for the selection of the patients will be chiefly based on the criteria suggested
2. Known cases of hypertension.
3. Patients between the age 20-70 years
4. Willing to participate in the study and informed consent
|
|
| ExclusionCriteria |
| Details |
• Patients suffering from hypertension along with I.H.D., C.H.D., C.A.D., coarctation of aorta
• Renal failure
• Endocrine diseases
• Hypertension with cerebral complications e.g. hypertensive encephalopathy, cerebral haemorrhage, convulsive seizure
• Malignant hypertension etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Routine haematological investigation such as Hb TC DC ESR .
2. Biochemical tests like blood urea serum creatinine serum cholesterol triglyceride HDL and fasting blood sugar and post prandial blood sugar.
3. Microscopic and routine examination of urine
4. Microscopic and routine examination of stool.
5. ECG and X-ray chest wherever required.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For the assessment of the therapy, The following scoring pattern will be followed. |
1 MONTH |
|
|
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)
|
18/02/2025 |
| 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="2"
Months="0"
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
|
The
whole research work will be summarized and conclusion will be made on the basis
of the observation which will be done on the subjective and objective
parameters. Result will be analyzed statically & discussed accordingly |