| CTRI Number |
CTRI/2025/05/086639 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study of Guduchi (Tinospora cordifolia) and Nagarmotha (Cyperus rotundus) on sthaulya roga |
|
Scientific Title of Study
|
Comparative analysis of the therapeutic effects of Guduchi (Tinospora cordifolia) and Nagarmotha (Cyperus rotundus) on sthaulya roga |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Kumar Pandey |
| Designation |
MD Ay scholar (Dravyaguna) |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna 800003 |
| Address |
Department of Dravyaguna Government Ayurvedic College and Hospital near budhmurti kadamkuan Patna 800003 BIHAR INDIA
Patna
BIHAR
800003
India |
| Phone |
8800204987 |
| Fax |
|
| Email |
avi220897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanno Gupta |
| Designation |
Professor Department of Dravyaguna |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna 800003 |
| Address |
Government Ayurvedic College and Hospital near budhmurti kadamkuan Patna 800003 BIHAR INDIA
Patna
BIHAR
800003
India |
| Phone |
8539038758 |
| Fax |
|
| Email |
guptashanno@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanno Gupta |
| Designation |
Professor Department of Dravyaguna |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna 800003 |
| Address |
Government Ayurvedic College and Hospital near budhmurti kadamkuan Patna 800003 BIHAR INDIA
Patna
BIHAR
800003
India |
| Phone |
8539038758 |
| Fax |
|
| Email |
guptashanno@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dravyaguna , OPD No-10 Government Ayurvedic College and Hospital near budh murti Kadamkuan Patna 800003 Bihar |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of Dravyaguna Government Ayurvedic College and Hospital near budhmurti kadamkuan Patna 800003 BIHAR |
| 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 Avinash Kumar Pandey |
Government Ayurvedic College and Hospital Patna 800003 Bihar |
Department of Dravyaguna OPD no-10 Government Ayurvedic College and Hospital Patna 800003 BIHAR
Patna
BIHAR |
8800204987
avi220897@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: guduchi and nagarmotha, Reference: charak sutra 21/22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: guduchi, Reference: charak sutra 21/22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -(2) Medicine Name: nagarmotha, Reference: charak sutra 21/22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing for trial and give written informed consent. 2.The age group of patients will be between 20-60 yrs. 3.Patients from either sex with classical sign and symptoms of sthaulya roga. 4.Patients with BMI more than 25 Kg per
m2. 5.Waist to Hip ratio (Males more than 0.90 and Females more than 0.80) according to WHO
|
|
| ExclusionCriteria |
| Details |
1.Patient suffering from serious disease limiting life expectancy like AIDS, Cancer, etc. 2.Patient suffering from systemic disorder like TB, Cardiac problems, Diabetes, Renal stricture, hepatic disorder, Hypothyroidism, Cushing syndrome & Hypersensitivity is excluded, which interfere with the present study. 3.Patients having any hereditary disposition. 4.Pregnant and lactating women. 5.Patients below 20 and above 60 years of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of sthaulya roga (obesity) |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the effectiveness of guduchi in sthaulya. 2.To assess the effectiveness of nagarmotha in sthaulya. 3.To evaluate the therapeutics role of guduchi and nagarmotha churna in sthaulya roga |
60 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 |
|
Date of First Enrollment (India)
|
18/06/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Obesity is a lifestyle disorder. This is a randomised, interventional, single blind trial and it will be conducted in Government ayurvedic college and hospital bihar in the department of dravyaguna. Guduchi panchang and Nagarmotha Kanda will be taken and grinded into fine powder. dose of each Guduchi Churna and Nagarmotha Churna will be 3 gm BD for 15 days and will be kept in airtight packing separately. the duration of trial is 60 days. |