| CTRI Number |
CTRI/2024/11/077232 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Parinamshula i.e.Pain during digestion of meal and to check effectiveness of Ajmoda churna
to decrease pain in Parinamshula i.e.Pain during digestion of meal. |
|
Scientific Title of Study
|
Single group before and after clinical study to evaluate the efficacy of ajamoda churna in parinamshula |
| 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 Sanket Bhagwat Kalyankar |
| Designation |
M.D. Scholar |
| Affiliation |
Ayurved Samhita S C.S.M.S.S. Ayurved Mahavidyalaya,Kanchanwadi,Chh. Sambhajinagar,431011 |
| Address |
Ayurved Samhita Siddhant Evum Sanskrit Departmeant C S M S S Ayurved MahavidyalayaKanchanwadi Chh. Sambhajinagar,431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8888145514 |
| Fax |
|
| Email |
sanket721998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Bhojraj |
| Designation |
Assitant Professor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya,Kanchanwadi,Chh. Sambhajinagar,431011 |
| Address |
Ayurved Samhita Siddhant Evum Sanskrit Departmeant, C.S.M.S.S. Ayurved Mahavidyalaya,Kanchanwadi,Chh. Sambhajinagar,431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7350561419 |
| Fax |
|
| Email |
bhojrajkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Bhojraj |
| Designation |
Assitant Professor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya,Kanchanwadi,Chh. Sambhajinagar,431011 |
| Address |
Ayurved Samhita Siddhant Evum Sanskrit Departmeant, C.S.M.S.S. Ayurved Mahavidyalaya,Kanchanwadi,Chh. Sambhajinagar,431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7350561419 |
| Fax |
|
| Email |
bhojrajkiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S. Ayurved Mahavidyalaya And Rugnalaya,Kanchanwadi,Chh. Sambhajinagar,431011 |
|
|
Primary Sponsor
|
| Name |
Samhita Siddhant Evum Sanskrit Departmeant, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya |
| Address |
Samhita Siddhant Evum Sanskrit Departmeant, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya,Kanchanwadi,Chh. Sambhajinagar,431011 |
| Type of Sponsor |
Private medical college |
|
|
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 Sanket BKalyankar |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya |
OPD No.13 of Department of Kayachikista and OPD no.16 of department of Shalyatantra of C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya,Kanchanwadi,Chh.Sambhajinagar
Aurangabad
MAHARASHTRA |
8888145514
sanket721998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARINAMASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ajamoda, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having symptoms of parinamshula.
2.Age Above 20 years and Below 30 Years.
3.Irrespective of sex and occupations.
|
|
| ExclusionCriteria |
| Details |
Patient having symptoms other than Parinamshula.
Known patient of duodenal ulcers,Peptic Ulcer etc.
Age group below 20 years and above 30 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Parinamshula symptoms scores(VAS Scale). |
At Baseline,3rd Day and 7th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant changes in BHUKTAM JEERYTI YAT SHULAM i.e.Abdominal pain during digestion period of meal. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
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
|
Objective: 1. To Clinically evaluate the effect of Ajamoda Churna in Parinamshula. 2.To Study Literature of Parinamshula.
Participants: 63 Adult diagnosed with Parinamshula meeeting inclusion and exclusion criteria from OPD and IPD of department of Kayachikista and department of shalyatantra C.S.M.S.S.Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Chh.Sambhajinagar.
Intervensions:
68 Patients : Ajamoda churna administered with Gaughrita as Anupaan.
Outcomes: 1.Changes in symptoms of pain during diagestion (i.e BHUKTAM_JEERYTI_YAT_SHULAM). 2.Changes in accompanied symptoms of Bhuktam_JEERYTI_YAT_SHULAM in Parinamshula.
Fallow up - Two Fallow up 1st on 3rd day 2nd on 7th day Time period- 1 week.
Data Analysis: Data will be analyzed using appropriate statistical method to compare the effectiveness of the interventions on the outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and informed consent from participants.
|