| CTRI Number |
CTRI/2022/07/043692 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
05/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
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Anti-obesity action of Agnimantha(Premna integrifolia Linn.).
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Scientific Title of Study
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Pharmacognostical study on Agnimantha with special reference to its role in Sthaulya (Obesity).
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
meghna |
| Designation |
Junior resident |
| Affiliation |
Banaras hindu university |
| Address |
Department of Dravyaguna vigyana Faculty of Ayurveda IMS-BHU Varanasi
Department of Dravyaguna vigyana Faculty of Ayurveda IMS-BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6280541275 |
| Fax |
|
| Email |
meghnajawali@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr K N Dwivedi |
| Designation |
Professor |
| Affiliation |
Banaras hindu university |
| Address |
Department of dravyaguna vigyana faculty of ayurveda IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765550189 |
| Fax |
|
| Email |
kndbhu@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
meghna |
| Designation |
Junior resident |
| Affiliation |
Banaras hindu university |
| Address |
Department of dravyaguna vigyana faculty of ayurveda IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6280541275 |
| Fax |
|
| Email |
meghnajawali@gmail.com |
|
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Source of Monetary or Material Support
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| Sir sunderlal hospital BHU Varanasi Uttar pardesh |
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Primary Sponsor
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| Name |
Deparment of dravyaguna |
| Address |
Department of dravyaguna , IMS BHU Varanasi Uttar pardesh- 221005 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| meghna |
Sir sunderlal hospital banaras hindu university |
Room no 11 department of dravyaguna opd SSH BHU varanasi
Varanasi
UTTAR PRADESH |
6280541275
meghnajawali@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee IMS BHU |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: sthaulya, (2) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Agnimantha ghana vati, Reference: Sushruta samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -500 mg tablet will be made .Total dose will be 2000mg | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Medohara guggulu, Reference: Rasa tantra sara va sidha prayaoga sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -tablet will be of 500 mg .total dose of tablet will be 3000mg per day in three divided doses. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age group ranging from 18-65 years.
2. Body Mass index > 30.00kg/m2 and ≤ 40.00kg/m2
3. Waist Circumference ≥ 102 cm for males and ≥ 88cm for females.
4. Waist: Hip ratio ≥ 0.95 for males and ≥ 0.80 for females.
5. Abnormal lipid profile.
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| ExclusionCriteria |
| Details |
1. Patient having BMI>40.00
2. Patient with IDDM and severe hypertension.
3. Patient with severe cardiac and endocrine disease.
4. Patient not giving consent.
5. Obesity due to medicines e.g., Steroids, Contraceptive pills etc.
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
1)Reduction in BMI , Body Weight, Waist circumference, Waist - hip ratio .
2)Improvement in Various components of Lipid profile (S. Cholesterol, S. Triglycerides, HDL, LDL, VLDL).
3)Improvement in subjective parameters like Gurugatrata (Heaviness in body) , Javoparodha (Inability to do work) , Daurbalya (Weakness) , Daurgandhya (Foul body odour), Ati Kshudha (Excessive hunger), Nidradhikya (Excessive sleep), Ati pipasa (Excessive thirst), Krichavyavayta (Difficulty in performing sexual act)
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3 months
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Secondary Outcome
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| Outcome |
TimePoints |
1)Improvement in subjective parameters like Gurugatrata (Heaviness in body) , Javoparodha (Inability to do work) , Daurbalya (Weakness) , Daurgandhya (Foul body odour), Ati Kshudha (Excessive hunger), Nidradhikya (Excessive sleep), Ati pipasa (Excessive thirst), Krichavyavayta (Difficulty in performing sexual act).
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15 days |
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Target Sample Size
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Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="63" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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15/07/2022 |
| Date of Study Completion (India) |
30/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Ayurveda defines health as a state of equilibrium of dosha, dhatu, agni,
mala, and tranquillity of soul, sense organs, and mind and not the mere
absence of disease. The imbalance of dosha, dhatu poshana kriya leads to risk
of Sthaulya (Obesity).
In this fast lifestyle, the stress at the workplace and lack of exercise
due to technological advancement has given birth to lifestyle disorders.
Obesity is one such grave disorder causing potential harm to humanity. Obesity
is defined as the abnormal or excessive fat accumulation in the adipose tissues,
to the extent that health may be impaired. This may be either due to
hypertrophy or hyperplasia of adipocytes or a combination of both. In Samhita and Nighnatu, Agnimantha
(Premna integrifolia Linn.) has been prescribed for treating Sthaulya
(Obesity). It possesses Tikta, katu, kashaya, madhur rasa, Laghu and
ruksha Guna, Ushna virya, Katu vipaka and is kaphavatshamaka. It
possesses the property of Kaphamedonivarana. So, the test drug seems to
be rationale for the treatment of Obesity. Drug Dose:
Agnimanthaghana vati -500mg (2 BD)
Medohara Guggulu -500mg (2 TDS )
Patient’s grouping:
Patient
will be screened according to the inclusion or exclusion criteria and those who
will full fill the inclusion criteria will be randomly allotted (Table method of
randomization) into two treatment groups.:
A total number of patients will be 70 and they will be divided into two groups i.e. -
A, and B. 35 patients will be in each group. The groups with their drugs will
be as follows:
- Group A: - Agnimantha
Ghana Vati (Trial drug)
- Group
B: Medohara
Guggulu (Control drug)
 TRIAL METHODOLOGY
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Group A
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Group B
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Agnimantha Ghana Vati
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Medohara Guggulu
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Dosage: 500mg (2 BD)
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Dosage: 500mg (2 TDS)
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Trial Group
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Control Group
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GDuration of treatment- 3 months In both group, patients were advised mental rest and physical exercise like walking 3 km daily, diet restrictions like avoidance of excess oily, spicy food, and excess sweets. Follow up – Every 30 days
ROUP
A
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GROUP
B
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