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CTRI Number  CTRI/2023/05/052414 [Registered on: 09/05/2023] Trial Registered Prospectively
Last Modified On: 16/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial on vaasathi kashayam in the management of raththa kothippu noi (Systemic hypertension) 
Scientific Title of Study   A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF VAASATHI KASHAYAM IN THE MANAGEMENT OF RATHTHA KOTHIPPU NOI (SYSTEMIC HYPERTENSION) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PREYADARSHENI K 
Designation  PG scholar 
Affiliation  Government Siddha Medical College, Tirunelveli  
Address  DEPARTMENT OF POTHU MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE, TIRUVANATHAPURAM MAIN ROAD, PALAYAMKOTTAI, TIRUNELVELI

Tirunelveli
TAMIL NADU
627002
India 
Phone  9791528783  
Fax    
Email  preyadarshenikrishnan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ProfDrAManoharan 
Designation  Head of the department 
Affiliation  Government Siddha Medical College, Palayamkottai 
Address  Room no 10, Department of PG Pothu Maruthuvam, Government Siddha Medical College, Tiruvanathapuram main road, Palayamkottai, Tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443886700  
Fax    
Email  drmanoharan25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ProfDrAManoharan 
Designation  Head of the department 
Affiliation  Government Siddha Medical College, Palayamkottai 
Address  Room no. 10, Department of PG Pothu Maruthuvam, Government Siddha Medical College, Tiruvanathapuram main road, Palayamkottai, Tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443886700  
Fax    
Email  drmanoharan25@gmail.com  
 
Source of Monetary or Material Support  
OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL 
Address  GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI 
Type of Sponsor  Government medical college 
 
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 PREYADARSHENI K  GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL  OP NO.10, IP NO.20,24, PG DEPARTMENT OF POTHU MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, TIRUVANATHAPURAM MAIN ROAD, PALAYAMKOTTAI, TIRUNELVELI
Tirunelveli
TAMIL NADU 
9791528783

preyadarshenikrishnan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE, PALAYAMKOTTAI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  VAASATHI KASHAYAM  DOSAGE: 30-60 ml FREQUENCY: Twice a day ROUTE OF ADMINISTRATION: orally ADJUVANT: Jaggery DURATION: 50 days 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Known Systemic Hypertensive patients
2.Grade 2 Hypertension (SBP 160-179 mmHg and/or DBP 100-109 mmHg)
3.Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  1.Age: Below 34 ; Above 66
2.Known Malignant hypertension
3.Ischemic heart diseases
4.Chronic kidney disease
5.Chronic liver disease
6.Secondary malignancy
7.Dyslipidemia
8.Diabetes mellitus – Type II
9.Smoking and Alcoholism. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome will be aimed at reducing systemic blood pressure. If during or after treatment, SBP less than or equal to 130mmHg and DBP less than or equal to 90mmHg, will be considered as successful outcome of the treatment.  50 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To collect various Siddha literatures and modern journals for literature review on RATHTHA KOTHIPPU NOI.
2.To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status.
3.To perform physicochemical, phytochemical, bio chemical analysis of VAASATHI KASHAYAM.
4.To evaluate safety profile for acute and sub-acute toxicity of -VAASATHI KASHAYAM.
5.To evaluate pharmacological activities of VAASATHI KASHAYAM.
6.To perform in-vitro, in-vivo studies.
7.To perform molecular docking studies on the trial drug in ACE inhibitor and Angiotensin receptor blocker activities.
8.To perform cell line studies for its anti-hypertensive activities.
9.To study about the prevalence of RATHTHA KOTHIPPU NOI in relation with diet and lifestyle.
10.To evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in RATHTHA KOTHIPPU NOI during trial period.
11.To evaluate modern parametric changes in RATHTHA KOTHIPPU NOI. 
50 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   21/05/2023 
Date of Study Completion (India) 25/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Still under review  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Brief summary of the results: The range of age among the recruited patients was 37-61 with a mean age of 50. Majority of patients belonged to 51-60 (52%) and 41-50 (32%) years of age. 58% were males and 42% were female. Increased visceral adiposity accounts for 65-75% of risk of hypertension in individuals with overweight/obesity. The BMI of recruited cases fall mainly under overweight (40%) and grade I obesity (32%) with minimum BMI of 20.30 (Normal), maximum BMI of 38.90 (Obese grade II) and mean BMI of 28.54 (overweight). Risk factors such as smoking (30%), tobacco chewing (2%), betel chewing (4%) and alcohol (14%) were surveyed during the time of recruitment. Among which, only smoking was found in considerable percentage of the subjects which might be likely due to dishonest responses with the fear of judgement (Berxi survey 2022). 44% and 38% of the patients showed poor and moderate physical inactivity establishing the causative association between physical inactivity and hypertension (A U Gamage 2021). About half of the patients had positive family history of hypertension (54%). Mixed diet pattern was followed among 78% of the subjects. The assessment of health status of the cases before and after intervention with VK using ISI, MoCA and SF-12 revealed significant improvement. VK markedly improved sleeplessness in patients from moderate severity insomnia (18.02) to no clinically significant insomnia (6.34) (p value <0.05 in paired T test). In MoCA scale, there was incremental improvement from 24.11 to 27.27 (No cognitive impairment) (p value <0.05 in paired T test). Short form-12 questionnaire before and after treatment showed significant improvement in physical health (from 39.28 to 51.46) and mental health (from 32.62 to 50.66) of the patients (p value <0.05 in paired T test). Patients with mean SBP of 162.12±8.68 and DBP of 98.32±7.71 were recruited in the study with minimum BP of 146/81 mmHg and maximum of 188/116 mmHg. Most of the patients belonged to vathapitham (24%), pithvatham (20%), pithakabham thegi (24%) and rasogunam (62%). Systemic examination according to Siddha parameters in accordance with symptoms such as profuse sweating, epiphora, redness of eyes, loss of appetite, ageusia, nausea, constipation/loose stools showed derangement of annamayakosam (94%), pranamayakosam (55%), manomayakosam (66%), abaanan (84%), samaanan (98%), analakam (94%), ranjakam (98%) and avalambagam (76%) which were improved markedly after intervention with VK (p value <0.05 in paired T test). In eight-step Siddha examination, sparisam (82%), naa (54%), malam (66%) and moothiram (48%) were affected. Among them, sparisam, malam and moothiram showed significant prognosis confirming the diuretic and laxative action of fruits of Vitis vinefera (B Salehi 2019). The blood parameters before and after treatment revealed meager improvement in Hemogloblin (from 12.40±1.52 g/dL to 12.99±0.99 g/dL) and HDL (from 39.48±3.53md/dL to 42.56±2.74mg/dL). Slight changes in Sodium (From 134.74 ± 4.94 mEq/L to 141.06 ± 2.05 mEq/L) and Potassium (From 3.36 ± 0.38 mEq/L to 3.98 ± 0.39 mEq/L) levels are noted. Even though Vitis vinifera was rich in fructose, there were notably better changes in the RBS (from 193.34±44.46mg/dL to 164.12±25.62mg/dL) and Cholesterol (208.52±34.97mg/dL to 181.46±16.01mg/dL) which may be due to confounding factors. On weekly assessment, there was marked improvement in SBP in second week of the trial whereas improvement in DBP were remarked only after the fourth week. Determining the potency of VK in control of hypertension (p value < 0.05 within the groups intercept in GLM repeated measures. There was notable improvement in clinical symptoms such as headache, sweating, insomnia, constipation and confusion with 50% of the patients responding to the treatment within 2 weeks of intervention.

 
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