| CTRI Number |
CTRI/2021/02/031371 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE COMBINED EFFECT OF PUNARNAVADDI YOGA (HERBAL FORMULATION) AND RUDRAKSHA KALKA LEHANA(RUDRAKSHA PASTE) IN GESTATIONAL HYPERTENSION |
|
Scientific Title of Study
|
A SINGLE ARM NON-RANDOMISED STUDY ON THE COMBINED EFFECT
OF PUNARNAVADI YOGA AND RUDRAKSHA LEHANA IN
GARBHAVASTHAJANYA UCHCHA RAKTA CHAPA VIS-A-VIS
GESTATIONAL HYPERTENSION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KRITHIKA N |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPT OF PRASOOTI TANTRA AND STREE ROGA SRI KALABYRAVESHWARA SWAMY
AYURVEDIC MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE
VIJAYANAGAR BENGALURU
VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA
560104
India |
| Phone |
9176888538 |
| Fax |
|
| Email |
krithika.ayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANUPAMA V |
| Designation |
PROFESSOR |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPT OF PRASOOTI TANTRA AND STREE ROGA SRI KALABYRAVESHWARA SWAMY
AYURVEDIC MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE
VIJAYANAGAR BENGALURU
VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANUPAMA V |
| Designation |
PROFESSOR |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPT OF PRASOOTI TANTRA AND STREE ROGA SRI KALABYRAVESHWARA SWAMY
AYURVEDIC MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE
VIJAYANAGAR BENGALURU
VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
Dr KRITHIKA N |
| Address |
SRI KALABYRAVESHWARA SWAMY
AYURVEDIC MEDICAL COLLEGE
HOSPITAL RESEARCH CENTRE VIJAYANAGAR BENGALURU |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KIRAN M GOUD |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE |
DEPARTMENT OF PRASOOTI TANTRA EVAM STREE ROGA, SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMC HRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O139||Gestational [pregnancy-induced] hypertension without significant proteinuria, unspecified trimester. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PUNARNAVADI YOGA AND RUDRAKSHA KALKA LEHANA |
Punarnavadi Yoga and Rudraksha kalka lehana will be given for 7 days. The per day dose of Punarnavadi yoga is 3g which will be given in divided dose of 500mg capsules
throughout the day in 6 doses and per day dose of Rudraksha kalka lehana is 1gm which will be given in
divided dose of 250mg throughout the day in 4 doses. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primi and multi gravida
Pregnant women having Blood Pressure – 140/90 – 160/110 mmHg after 20 weeks of gestation.
|
|
| ExclusionCriteria |
| Details |
Pregnancy associated with any gynecological complications that will interfere with the course of study.
Pregnancy associated with any Obstetric complications that will interfere with the course of study.
Pregnancy associated with Proteinuria: more than 3+.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in high blood pressure |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/03/2021 |
| 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="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypertensive disorders of pregnancy occur in about 10% of all pregnant women around the world. Preeclampsia is a complication of gestational hypertension which affects 3–5% of pregnancies. In Asia and Africa, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy. In India, the incidence of preeclampsia is reported to be 8%-10% among the pregnant women. According to a study, the prevalence of hypertensive disorders of pregnancy was 7.8% with preeclampsia in 5.4% of the study population in India. 1 Young and nulliparous women are particularly vulnerable to developing preeclampsia, whereas older women are at greater risk for chronic hypertension with superimposed preeclampsia. The incidence is markedly influenced by race and ethnicity—and thus by genetic predisposition. Diseases of pregnant woman due to foetus are called as ‘Garbhopadrava’ or ‘Garbhini vyadhi’ in Ayurveda. Garbhini shotha (oedema) is one of the Garbhopadrava mentioned in our Ayurvedic classics. Oedema of pregnancy may be of different origin. Ayurveda has described ‘Garbha Sampidana ’ as a causative factor of Shotha (oedema) of pregnancy. Shotha is one of the symptoms in gestational hypertension. As there is no actual description of garbhavasthajanya uchcha raktachapa in our Ayurvedic classics, the same has been used as a coined term. Early detection and appropriate treatment are the need of the hour to reduce the maternal and fetal mortality and morbidity. The standard protocol of anti-hypertensive drugs though highly effective and lifesaving has its own side effects that include fatigue, lethargy, exercise intolerance, sleep disturbance, bronchoconstriction etc,. Hence, an effective formulation in Ayurveda which is devoid of harmful drug interactions and side effects will be of immense help for women of present era and needless to say for the foetus. In this study Punarnavadi yoga is an anubhuta yoga containing Punarnava, Darbha and Gokshura along with Rudraksha kalka lehana which aims to manage the gestational hypertension. |