| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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. |