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CTRI Number  CTRI/2025/06/088727 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To see effect of Vayasthapana Mahakshaya herbal drug in the management of Akalaja Jara (Premature Ageing) 
Scientific Title of Study   A clinical trial to evaluate the efficacy of Vayasthapana Compound in the management of Akalaja Jara w.s.r to Premature Ageing 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muskan 
Designation  PG Scholar 
Affiliation  KSVAMC RC Gangoh 
Address  Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh

Saharanpur
UTTAR PRADESH
247341
India 
Phone  9034002170  
Fax    
Email  muskankaushik.in@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shagufta Malhotra 
Designation  Associate Professor  
Affiliation  KSVAMC RC Gangoh 
Address  Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh

Saharanpur
UTTAR PRADESH
247341
India 
Phone  9988646655  
Fax    
Email  shagufta.malhotra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Muskan 
Designation  PG Scholar 
Affiliation  KSVAMC RC Gangoh 
Address  Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh

Saharanpur
UTTAR PRADESH
247341
India 
Phone  9034002170  
Fax    
Email  muskankaushik.in@gmail.com  
 
Source of Monetary or Material Support  
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh, Saharanpur -247341 
 
Primary Sponsor  
Name  Dr Muskan 
Address  Kunwar Shekhar Vijendra Ayurved Medical College and Reseach Centre Gangoh Saharanpur-247341 
Type of Sponsor  Other [Self] 
 
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 Muskan  Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur-247341  OPD & IPD of Kayachikitsa department Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur
Saharanpur
UTTAR PRADESH 
9034002170

muskankaushik.in@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R54||Age-related physical debility. Ayurveda Condition: jara,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vayasthapana Compund, Reference: Charak Sutra Sthan Chapter 4,, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: godugdha), Additional Information: Vayasthapana Mahakashaya
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients between age of 31 to 50 years of age with clinical features of Akalaja Jara(Premature ageing)
2.Patients of either sex,irrespective of their caste,religion etc.
3.Patient willing to give informed consent to participate in trial. 
 
ExclusionCriteria 
Details  1.Patient less than 31 years and more than 50 years of age
2.Patients diagnosed with any major diseases like carcinoma.
3.Patients with any chronic disease or Dhatukshayatva involved in the pathophysiology of disease like Madhumeha, Rajyakshama.
4.Patients diagnosed with any systemic disorders like cardiovascular disorders, hepatic disorders, renal disorders and cerebrovascular disorders.
5.Pregnant and lactating mothers.
6.Females in Perimenopausal phase having symptoms like irregular menstruation, flashes and
night sweats etc.
7.Patient had completed participation in any other clinical trial in past 6 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in sign and symptoms of Akalaja Jara  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in quality of life
2.Time taken to walk a distance of 10 metres.
3.Number of Sit- ups done by the patient in one minute.
4.BMI of the patient. 
90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   07/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/01/2026 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ageing is a universal process that began with the origin of life. It is defined as the process of growing old, damage to cells, tissues and organs with the passage of time. It is a complex, systemic physiological process characterized by progressive degradation, loss of function, and reduced repair capacity of tissues, cells, organ and make us more susceptible to death. Chronological aging is an irreversible process but the factors causing biological aging can be controlled. We have chosen the drugs of Vayasthapan mahakashaya as mentioned in Charaka Samhita Sutrasthan chapter 4. In classics, it is mentioned that Vayasthapana drugs improves the quality of life, memory, youthfulness and brightness etc. It prevents ill health and block geriatric symptoms. This study is designed to identify the effect of Compund drugs from Vayasthapana mahakashaya to improve the sign and symptoms of Premature Ageing. A clinical study will be conducted to see the efficacy of Vayasthapana Compound churna in improving the signs and symptoms of Akalaja Jara (Premature Ageing). At first, all participants will be screened to check their eligibility for the study. A total of 60 clinically diagnosed patients will be enrolled in this study after taking informed written consent. After that, the first assessment will be done before drug administration with a validated questionnaire and grading will be done according to the signs and symptoms of the patients. Then the drug therapy will be started and the total duration will be 90 days. Three follow ups will be done each after 30 days. The last assessment will be done on the 90th day and the grading will be given again to see the changes in the signs and symptoms of Akalaja Jara . Signatures on informed consent and patient information sheets will be taken on hard copy, and all other relevant data for the study will be collected. After the collection of all the relevant data, the analysis of the data will be done. 


 
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