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CTRI Number  CTRI/2015/03/005634 [Registered on: 13/03/2015] Trial Registered Prospectively
Last Modified On: 13/01/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the effects of some Ayurvedic formulations in the management of High blood pressure. 
Scientific Title of Study   Clinical trial of Parthadyarishta (Arjunarishta) and Sarpagandha Vati in the management of Essential Hypertension (Uccha Raktachap) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K K Singh 
Designation  Research Officer (Ay.) 
Affiliation  Ayurveda Regional Research Institute, Patna 
Address  Ayurveda Regional Research Institute, RMRI Campus, D-Block, Agamkuan, Patna-7,Bihar
Ayurveda Regional Research Institute, RMRI Campus, D-Block, Agamkuan, Patna-7,Bihar
Patna
BIHAR
800007
India 
Phone  9431039291  
Fax  0612-2631678  
Email  kks_pat@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr K K Singh 
Designation  Research Officer (Ay.) 
Affiliation  Ayurveda Regional Research Institute, Patna 
Address  Ayurveda Regional Research Institute, RMRI Campus, D-Block, Agamkuan, Patna-7,Bihar
Ayurveda Regional Research Institute, RMRI Campus, D-Block, Agamkuan, Patna-7,Bihar
Patna
BIHAR
800007
India 
Phone  9431039291  
Fax  0612-2631678  
Email  kks_pat@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr K K Singh 
Designation  Research Officer (Ay.) 
Affiliation  Ayurveda Regional Research Institute, Patna 
Address  Ayurveda Regional Research Institute, RMRI Campus, D-Block, Agamkuan, Patna-7,Bihar
Ayurveda Regional Research Institute, RMRI Campus, D-Block, Agamkuan, Patna-7,Bihar
Patna
BIHAR
800007
India 
Phone  9431039291  
Fax  0612-2631678  
Email  kks_pat@yahoo.co.in  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, New Delhi 
 
Primary Sponsor  
Name  Central Council For Research In Ayurvedic Sciences 
Address  Central Council For Research In Ayurvedic Sciences Address-Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan61-65, Institutional Area, Opposite D-Block, Janakpuri,New Delhi-110058  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KK Singh  Ayurveda Regional Research Institute Patna  Room No.11,Out Patient Deptt.,A.R.R.I.,RMRI Campus,D-BlockAgamkuan Patna-7,Bihar.
Patna
BIHAR 		 0612-2631678
0612-2631678
kks_pat@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Essential Hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  PARTHADYARISHTHA(ARJUNARISHTA)along with SARPAGANDHA VATI.  PARTHADYARISHTHA(ARJUNARISHTA)- Dose of 20 ml twice daily; Dosage form- Arishta (fermented liquid); Route of Administration-Oral; Time of Administration-Twice a day after food; Anupana-Water (in equal quantity i.e. 20 ml);Packing form- A combi pack with one bottle containing 450 ml and one bottle containing 150ml along with a measuring cap. Duration of therapy-12 weeks. SARPAGANDHA VATI- Dose of 500 mg(1tablets) twice daily; Dosage form-Tablet of 500 mg; Route of Administration-Oral; Time of Administration-Twice a day after food; Anupana-Water; Packing form-15gm (30 Tablets of 500 mg); Duration of therapy-12 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Diagnosed patients of essential hypertension S.B.P. ≥ 140 Hg. and_< 159 Hg.& D.B.P.≥ 90 Hg. and _< 99 Hg mm. Hg (Hypertension Stage-1,as per JNC VII report,2004)
2. Willing and able to participate for 14 weeks
 
 
ExclusionCriteria 
Details  1. Known clinical diagnosed cases of coronary diseases
2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
3. Symptomatic patients with clinical evidence of Heart failure.
4. Secondary hypertension.
5 Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >

1.2mg/dl, uncontrolled Pulmonary Dysfunction(asthmatic and COPD patients) or other concurrent severe disease.
6.Patients with Diabetes Mellitus {B.S. (F) > 126 mg/dl and / or B.S. (2 hr. PP)>200 mg/dl}
7. Women who are pregnant or lactating.
8. Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
9. Alcoholics and/or drug abusers.
10.Serum Triglycerides ≥ 250 mg/dl
11.Patients with evidence of malignancy
12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
13. H/o hypersensitivity to any of the trial drugs or their ingredients.
14. Patients who have completed participation in any other clinical trial during the past six (06) months.
15. Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes from baseline measurements in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.

 		 At baseline, 14, 28, 42,56,70,84 and at the end of follow up after 14 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in the SF-36-Health Survey Score.
2.Change in Hamilton Anxiety Rating Scale (HAM – A) Score

 		 1. At baseline, 84 and at the end of follow up after 14 weeks.
2. At baseline, 14, 28, 42,56,70,84 days and at the end of follow up after 14 weeks. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   15/04/2015 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   To be published after the completion of the clinical trials in the center. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Ayurveda Regional Research Institute, Patna, is a clinical research institute and is a peripheral institute of the Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, and Government of India and is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine, aimed at generating evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations. This is a single centric trial being initiated in Essential Hypertension (Uccha Raktachapa)”  disease at Ayurveda Regional Research Institute (ARRI), Patna, of the Council as an activity under the Intra Mural Clinical Research Programme (IMCRP).

 

Parthadyarishtha (Arjunarishtha) is  a  fermented  liquid  preparation  made  with  the  ingredients  in  the formulation containing Partha (Arjuna) (Terminalia arjuna), Mridvika (Vitis vinifera), Madhupushpa (madhuka indica),Jala (water) for decoction, Dhataki (Woodfordia fruticosa) and Guda (jaggery).

                                                                                                                                   

Sarpagandha Vati is prepared by air dried root of Rauwolfia serpentina.

 

The present study entitled “Clinical Evaluation of Parthadyarishtha (Arjunarishta) and Sarpagandha Vati in the Management of Essential Hypertension (Uccha Raktachapa)” is being undertaken in this peripheral institutes (Ayurveda Regional Research Institute (ARRI)), Patna of the CCRAS.

 

The evidence generated as an activity under the IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations. 
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