| CTRI Number |
CTRI/2025/04/084023 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sheetali pranayama on patients of Hypertension |
|
Scientific Title of Study
|
Anatomical consideration of Hridaya(Anahata) chakra and its applied anatomy with special reference to Stage 1 Hypertension and cardiac electrical parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri R |
| Designation |
MD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Rachana Sharir, Faculty of Ayurveda, IMS BHU Varanasi, Uttar pradesh, Pin- 221005
Department of Rachana Sharir, Faculty of Ayurveda, IMS BHU Varanasi, Uttar pradesh, Pin- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7012520137 |
| Fax |
|
| Email |
gaya97radhakrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri R |
| Designation |
MD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Rachana Sharir, Faculty of Ayurveda, IMS BHU Varanasi, Uttar pradesh, Pin- 221005
Department of Rachana Sharir, Faculty of Ayurveda, IMS BHU Varanasi, Uttar pradesh, Pin- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7012520137 |
| Fax |
|
| Email |
gaya97radhakrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
H H Awasthi |
| Designation |
Senior Professor and HOD |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Rachana Sharir, Faculty of Ayurveda, IMS BHU Varanasi, Uttar pradesh, Pin- 221005
Department of Rachana Sharir, Faculty of Ayurveda, IMS BHU Varanasi, Uttar pradesh, Pin- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415813194 |
| Fax |
|
| Email |
hhawasthi10@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal Hospital, IMS BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science, Banaras Hindu University |
| Address |
Institute of Medical Science, Banaras Hindu University, Varanasi, pin 221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri R |
Sir Sunderlal Hospital |
Department of Kayachikitsa OPD Room NO 21 and 22 Indian Medicine Wing FOA IMS BHU Varanasi UTTAR PRADESH 221005
Varanasi
UTTAR PRADESH |
7012520137
gaya97radhakrishnan@gmail.com |
| Dr Gayathri R |
Sir Sunderlal Hospital |
Department of Cardiology OPD ROOM NO 103 IMS BHU Varanasi UTTAR PRADESH 221005
Varanasi
UTTAR PRADESH |
7012520137
gaya97radhakrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Institute of Medical Sciences Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Group A with Control (Telmisartan - 20 mg - as per ESH guidelines) | Telmisartan 20 mg once daily after food | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarpagandhaghan vati, Reference: Siddha Yoga Sangraha- Bhrama Anidra Unmada Adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 3 Months, Reference: Yes, Route: -Water, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: Sheetali pranayama and Yoganidra, Ritucarya: , Acara Rasayana:, Other:along with Telmisartan 20 mg , Pathya/Apathya:, Pathya:, Apathya: | | 4 | Intervention Arm | Lifestyle | - | - | Dinacarya: Sheetali pranayama and Yoganidra, Ritucarya: , Acara Rasayana:, Other:along with Sarpagandhaghan vati 250 mg twice daily, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to give consent to participate in the study.
Patients in age group between 40-60 years of either sex irrespective of religion, socio- economic status and occupation.
Patients having Grade1 Hypertension (SBP= 140-159mmHg & DBP= 90-99mmHg). |
|
| ExclusionCriteria |
| Details |
Patients age less than 40 or greater than 60 years.
Patients with less than 140/90 mmHg and greater than 159/99 mmHg blood pressure.
Patients with Diabetes Mellitus, thyroid disorders.
Patients on steroid medicines or having Peptic ulcer.
Subjects who are pregnant and lactating.
Patients with habits of smoking and alcoholism.
Subjects who are with chronic illness except metabolic syndromes.
Patients with critical illness like cancer, HIV etc. or hearing impairment.
Subjects who are taking any kind of sedatives or psychological treatments.
Subjects who are having other renal, hepatic, cardiovascular or respiratory disorders (such as asthma, bronchitis, or excessive mucus). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Systolic and diastolic blood pressure |
3 months with follow up at 1 month interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BMI
RFT
LFT
Lipid profile
CBC |
3 months with follow up at 1 month interval |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
140 cases of Stage 1 Hypertension will be included in the
interventional study which will be randomly divided into 4 groups of 35
patients in each group. First group will be the control group prescribed with
Telmisartan 20mg. Second group will be prescribed with Telmisartan 20mg along
with Sheetali pranayama and Yoganidra. Third group will be prescribed with
Sarpagandha ghanvati 250 mg twice daily. Fourth group will be prescribed with Sarpagandha
ghanvati 250 mg twice daily along with Sheetali pranayama and Yoganidra. It is expected that Sheetali pranayama and Yoganidra will reduce blood pressure in patients. |