| CTRI Number |
CTRI/2024/08/072187 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Ayurvedic Formulation of brihat agnimanth and laghu agnimanth in the Management of obesity |
|
Scientific Title of Study
|
A pilot study to compare pharmacognostical, phytochemical, and therapeutic effect of Brihat Agnimantha (Premna integrifolia) and Laghu Agnimantha (Clerodendrum phlomidis) mool kwath in the management of Sthaulya (obesity). |
| 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 Rakesh Kumar |
| Designation |
MD Scholar Dravyaguna dept |
| Affiliation |
Institue for Ayurved studies and Research |
| Address |
OPD NO 58 Dravyaguna dept Institue for Ayurved studies and Research kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9991586478 |
| Fax |
|
| Email |
yadavrakesh45689@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Satyender Kumar |
| Designation |
Associate Professor PG Department of Dravyaguna |
| Affiliation |
Institue for Ayurved studies and Research |
| Address |
OPD NO 58 Department of Dravyaguna Institue for Ayurved studies and Research kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9665026320 |
| Fax |
|
| Email |
satyender70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
MD Scholar Dravyaguna dept |
| Affiliation |
Institue for Ayurved studies and Research |
| Address |
OPD NO 58 Dravyaguna deptInstitue for Ayurved studies and Research kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9991586478 |
| Fax |
|
| Email |
yadavrakesh45689@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institue for Ayurved studies and Research kurukshetra Haryana India 136118 |
|
|
Primary Sponsor
|
| Name |
Institue for Ayurved Studies and Research |
| Address |
sector 8 Kurukshetra Haryana India 136118 |
| Type of Sponsor |
Government 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 Rakesh Kumar |
Institue for Ayurved studies and Research Hospital |
OPD NO 58 Institue for Ayurved studies and Research sector 8 kurukshetra
Kurukshetra
HARYANA |
9991586478
yadavrakesh45689@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Shri Krishna Ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
STHAULYA |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: laghu Agnimanth, Reference: charak sutra 21/24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BRIHAT AGNIMANTH, Reference: CHARAK SUTRA 21/24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having Clinical sign & symptom of Sthaulya as per Ayurvedic text.
2.Patient either sex between the Age group of 18 - 60year .
3.Patient having BMI more than or equal to 25kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Patient below the age of 18 years and above 60 years
2.Patient of any chronic diseases
3.Pregnant and lactating women
4.Discontinuation criteria
Any Acute or Severe Illness.
Patient not willing to continue the treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the sign and symptoms of Sthaulya(Obesity). |
After treatment of 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the subjective parameters. |
after treatment period of 60 days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2024 |
| 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="0"
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
|
The study presented focuses on the pharmacognostical, sephytochemical, and therapeutic aspects of two species of Agnimanth Brihat Agnimanth Premna integrifolia and Laghu Agnimanth Clerodendrum phlomidis in the context of treating Sthaulya obesity in Ayurveda
Pharmacognostical Study This involves the identification and standardization of Agnimanth species, crucial for authentication and prevention of adulteration. Initial research highlighted variations in pharmacognostical characteristics and phytochemical profiles between the two species.
Phytochemical Study Evaluating the constituents of Agnimanth species and their decoctions Kwath is essential to understand their bioactive components and therapeutic potential. Such studies aim to establish similarities or differences in formulations derived from these species.
Therapeutic Study Ayurvedic texts like Charak Samhita advocate Agnimanth as a treatment for Sthaulya, emphasizing its role in balancing doshas and improving Jatharagni to manage pathological increases in appetite. Modern research underscores the need to identify the most effective Agnimanth species for obesity management.
The need for pharmacognostical and phytochemical studies precedes therapeutic investigations, ensuring the identification and standardization of plant materials. This foundational work is essential for validating Ayurvedic treatments and developing effective herbal formulations.
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