| CTRI Number |
CTRI/2024/03/064680 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of ayurveda in management of pre mature ageing. |
|
Scientific Title of Study
|
Efficacy Of Virechana Karma Followed By Triphladi rasayana And The Triphaladi rasayana Only In The Management Of Pre Mature Ageing(Akalaja Jara)–An Open Labelled Randomized Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiksha V Sayani |
| Designation |
MD Scholar |
| Affiliation |
Institute Of Teaching and Research In Ayurveda ,Jamnagar |
| Address |
Department Of Panchakarma,4TH Floor Institute Of Teaching And Research In Ayurveda.
Jamnagar
GUJARAT
361008
India |
| Phone |
8000539063 |
| Fax |
|
| Email |
pratikshasayani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
HOD |
| Affiliation |
Institute Of Teaching and Research In Ayurveda ,Jamnagar |
| Address |
Department Of Panchakarma,4TH Floor,Institute Of Teaching and Research In Ayurveda Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
HOD |
| Affiliation |
Institute Of Teaching and Research In Ayurveda ,Jamnagar |
| Address |
Department Of Panchakarma,4TH Floor room No.424, Institute Of Teaching and Research In Ayurveda,Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Teaching and Research In Ayurveda ,Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute Of Teaching and Research In Ayurveda ,JAMNAGER |
| Address |
Opp. B-Division Police Station, Gurudwara Road, Jamnagar, Gujarat 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pratiksha V Sayani |
PG Hospital ,Institute of Teaching and Research in Ayurveda |
OPD 14,PG Hospital ,Institute of Teaching and Research in ayurveda
Jamnagar
GUJARAT |
8000539063
pratikshasayani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Institute of Teaching and Research in ayurveda,Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R54||Age-related physical debility. Ayurveda Condition: VAYAH/KALAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Rasayana, Reference: Charak Samhita, Chikitsa Sthan chapter 1, Pada 3, Verse 45 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu+ghrit), Additional Information: - | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: charak samhita Kalp sthan 1/5, Procedure details: deepan pachan for -3 to 7 days
sodhanarth sneh pan for go ghruta _ 3 to 7 day
sarvang abhyang evam bashp swedan for 4 days
virechana karma for 1 day
samsarjan karma)
(1) Medicine Name: Trivrit avelah, Reference: astang hrdayam kalp siddhi sthan 2/9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 100(g), Frequency: od, Duration: 15 Days |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to paricipate in the study.
Patients indicated for virechana karma. |
|
| ExclusionCriteria |
| Details |
Patient with any type of psychiatric disorder like Alzheimers diseases,parkinsonism .
Patient with any systemic diseases like uncontrolled hypertention,diabetes
mellitus,tuberculosis,carcinoma ,or any genetic disorder and syndromes.
Patient contraindicated for Virechana karma. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be Improvement in SF 36 score After Completion of Treatment. |
Group A 44 to 54 days
Group B 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| grey/white hair scale score and Facial Wrinkles score |
44 TO 54 DAYS in GROUP A
30 DAYS IN GROUP B |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
25/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The title of our research project is“EFFICACY OF VIRECHANA KARMA FOLLOWED BY TRIPHALADI RASAYANA AND TRIPHALADI RASAYANA ONLY IN THE MANAGEMENTOF PRE MATURE AGEING(AKALAJA JARA)–AN OPEN LABELLED RANDOMIZED COMPARATIVE CLINICAL TRIALâ€
Introduction: Ageing is progressive physiological changesin an organism thatlead to decline of biological functions and of the organism’s ability to adapt to metabolic stress.According to WHO the elderly has been defined as the chronological age of 60 year. Due to Exposure to UV radiation, long-term stress conditions, lack of physical exercise, improper diet and use of stimulants by this Excessive formation of free radicals which contributes to oxidative stress, causing damage at the molecular and cellular level. Reactive oxygen species in vitro cause chemical modifications as well as damaging effects to proteins , lipids, carbohydrates and nucleotides , which can contribute to pre mature ageing. The Triphaladi rasayana is mainly concerned with immune system strengthening which “Reduce oxidative stress, boost antioxidant defenses, and promote rejuvenationiv. Sodhanais necessory prior to rasayana to increase effect of Rasayana. Significance:As the incidence of premature ageing is increasing globally, it has become a burning issue to take major steps for its prevention and treatment. Conventional system of medicine has limited approach regarding its prevention and treatment. In Ayurveda, Geriatrics is considered as a separate branch among 8 branches of Ayurveda, is limited approach regarding its prevention and treatment. In Ayurveda, Geriatrics is considered as a separate branch among 8 branches of Ayurveda, is also becoming a major medical speciality globally. Yet there is a necessity for persuing further research to find out some safe and effective therapy. Taking all above fact into consideration, this topic was selected to find a measure that could help to improve quality of life.
Aim & Objectives: To assess and compare the efficacy of Virechana karma and Triphaladi rasayana in Pre mature ageeing (Akalaja jara).
Materials and Methods: 30 Patients of Pre Mature Ageing will be enrolled in two groups. Group A patients will receive intervention Virechana karma followed by Triphaladi rasayana.Group B patients will receive Triphaladi rasayana.
Results and Discussion: Results: Virechana followed by Triphaladi Rasayana (Group A) produced significant and widespread improvements in facial wrinkles, particularly in the forehead, glabellar, periorbital region, cheeks, nasolabial folds, upper lip, corners of the mouth, and neck, with minimal changes in preauricular and lower lip lines. These improvements persisted after 15 days of follow-up. Triphiladi Rasayana alone (Group B) showed modest improvement in wrinkles, mainly in the forehead and periorbital lines. Both groups showed highly significant improvement in SF-36 scores, while Group A demonstrated superior outcomes in wrinkle reduction and Grey/White Hair Score compared to Group B, indicating overall better effectiveness of the combination therapy.Discussion: Premature ageing (Akalaja Jara) results from Pitta-pradhana Tridosha aggravation causing Agni imbalance, Srotorodha, and Dhatu-ksaya, with Pittaja prakriti individuals being more susceptible; Virechana Karma clears Pitta and Srotorodha, Triphaladi Rasayana nourishes Dhatus and delays degeneration, and their combination shows superior improvement in wrinkles, hair pigmentation, and quality of life
Follow up: After completion of therapy, follow up will be done after 15 day to assess the status of patient, where patient will be asked to report.
Adverse effects: This drug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar. |