| CTRI Number |
CTRI/2012/05/002663 [Registered on: 18/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
08/05/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulations in the patients of High Blood Pressure |
|
Scientific Title of Study
|
Clinical Evaluation of Ashwagandhadyarishta, Jatamamsi Arka and Sarpagandha Vati in the Management of EssentialHypertension (Uccha Raktachapa) |
| Trial Acronym |
ACT- HTN-2010 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
New Delhi
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
New Delhi
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
New Delhi
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities: 1.Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola, District Kangra-176115, Himachal Pradesh, India.2.National Institute of Ayurveda (NIA), Amer Road, Madhav Vilas Palace, Jaipur-302002, Rajasthan, India.3.Tilak Ayurved Mahavidyalaya, 583 / 2, Rasta Peth, Pune-411011, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
| Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Ajay Kumar SharmaDr Pratibha Tiwari |
National Institute of Ayurveda (NIA) |
Department of Kayachikitsa, Amer Road, Madhav Vilas Palace,Jaipur-302002, Rajasthan, India.
Jaipur
RAJASTHAN |
09414250295
0141-2635709
pasharma_jpr@yahoo.com |
| Dr Vijay ChaudharyDr Toshi Agarwal |
Rajiv Gandhi Government Post-Graduate Ayurvedic College |
Department of Kayachikitsa, Paprola, District Kangra-176115, Himachal Pradesh, India
Kangra
HIMACHAL PRADESH |
9418130228
01894242064
drvijaychaudhary@gmail.com |
| Dr AJ ShimpiDr Mallesh R Kulal |
Tilak Ayurved Mahavidyalaya |
Department of Kayachikitsa, 583/2, Rasta Peth, Pune-411011, Maharashtra, India
Mumbai
MAHARASHTRA |
9370097917
02026336428
shriyashimpi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda (NIA), Jaipur |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola |
Approved |
| Institutional Ethics Committee, Tilak Ayurved Mahavidyalaya, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Essential Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASHWAGANDHADYARISHTA ALONG WITH SARPAGANDHA VATI AND JATAMAMSI ARKA |
ASHWAGANDHADYARISHTA: Dose – 25 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;Packing form- 400 ml pet bottle;
Duration of therapy-12 weeks; Along With SARPAGANDHA VATI: Dose – 1 gm (2 tablets) twice daily; Dosage form – Tablets of 500 mg; Route of Administration – oral; Time of Administration-Twice a day after food; Anupana-Water; Packing form- 30 gm (a plastic jar containing 60 tablets); Duration of therapy-12 weeks; And JATAMAMSI ARKA :Dose – 10 ml twice daily; Dosage form – Arka (liquid); Route of Administration – oral; Time of Administration-Twice a day before food; Anupana-Water; Packing form- 300 ml pet bottle; Duration of therapy-12 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged 18 years and above.
2. Diagnosed patients of essential hypertension with:
S.B.P. < 159 mm. Hg. and ≥ 140 mm Hg.
D.B.P. ≤ 99 mm. Hg. and > 90 mm. Hg
(Hypertension Stage –1, as per JNC VII report, 2004)
3. Willing and able to participate for 16 weeks |
|
| ExclusionCriteria |
| Details |
1. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
2. Symptomatic patients with clinical evidence of Heart failure.
3. Secondary hypertension.
4. 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.
5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)
>200 mg% OR HbA1c> 6.5%}
6. Women who are pregnant or lactating.
7. Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
8. Alcoholics and/or drug abusers.
9. Serum Triglycerides ≥ 250 mg/dl
10. Patients with evidence of malignancy
11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
12. H/o hypersensitivity to any of the trial drugs or their ingredients.
13. Patients who have completed participation in any other clinical trial during the past six (06) months.
14. Any other condition which the P.I. thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes from baseline measurements in mean sitting systolic blood pressure and mean sitting diastolic blood pressure. |
at Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in the SF-36-Health Survey Score.
• Change in Hamilton Anxiety Rating Scale (HAM – A) Score. |
SF-36 Survey Score-Baseline, 84th day and at the end of follow up after 16 weeks.
HAM-A score-at Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
24/02/2011 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published after the completion of the clinical trials in all the three centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aimed at scientific validation of the clinical efficacy and safety of
twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre
clinical trials have been initiated as an activity under the Ayurveda Clinical
Trials (ACT) project of the Ayurvedic Pharmacopoeia committee (APC) during
August 2010 in eighteen (18) disease conditions involving fifty four (54)
M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges
across the country.
Asvagandhadyarista is a
fermented liquid preparation containing
Asvagandha (Withania somnifera), Musali (Chlorophytum tuberosum), Manjistha
(Rubia cordifolia), Haritaki (Terminalia chebula), Haridra (Curcuma longa),
Daruharidra (Berberis aristata), Madhuka (Glycyrrhiza glabra), Rasna (Pluchea lanceolata),
Vidari (Pueraria tuberosa), Arjuna (Terminalia arjuna), Musta (Cyperus
rotundus), Trivrta (Ipomoea turpethum), Sveta Sariva (Hemidesmus indicus),
Krsna Sariva (Cryptolepis buchanani), Sveta Candana (Santalum album), Rakta
Candana (Pterocarpus santalinus), Vaca (Acorus calamus), Citraka (Plumbago
zeylanica), Dhataki (Woodfordia fruticosa), Shunthi (Zingiber officinale), Maricha
(Piper nigrum), Pippali (Piper longum), Tvak (Cinnamomum zeylanicum), Patra (Cinnamomum tamala), Priyangu
(Callicarpa macrophylla), Sukshma ela (Elettaria cardamomum), Nagakesara (Mesua
ferrea) and Honey.
Jatamamsi Arka is a liquid
preparation obtained by hydro-distillation of rhizomes of Nardostachys
jatamansi.
Sarpagandha Vati is
prepared by air dried root of Rauwolfia serpentina.
The present study is being undertaken in three post graduate Ayurveda
colleges to scientifically study and validate the clinical efficacy and safety
of Ashwagandhadyarishta,
Jatamamsi Arka and Sarpagandha Vati- classical Ayurvedic formulation. These formulations have been in use
since ages and found to be useful in treating Essential Hypertension (Uccha
Raktachapa) and promoting the
health.
The Central
Council for Research in Ayurvedic Sciences (CCRAS) is the nodal
organization to co-ordinate and monitor these trials. CCRAS has provided the
necessary infrastructure to the participating colleges, technical inputs
(including the clinical trial protocols), trial drugs and training to the
researchers involved in the project.
|