| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R54||Age-related physical debility. Ayurveda Condition: jara, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |