| CTRI Number |
CTRI/2024/08/073131 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Difference between Gorakhmundi vati and Hingwadi vati in the management of Vishada ( mild depression). |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Gorakhmundi vati versus Hingwadi vati with adjuvant therapy of Marma Chikitsa in the management of Vishada( mild depression)- Rodomized Controlled Trial. |
| 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 Hemangi Patil |
| Designation |
PG scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Salod, Wardha. |
| Address |
Room no.30, Department of Kayachikitsa,Mahatma Gandhi Ayurveda College, Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7972817954 |
| Fax |
|
| Email |
hem16998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangi Patil |
| Designation |
PG scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Salod, Wardha. |
| Address |
Room no.30, Department of Kayachikitsa,Mahatma Gandhi Ayurveda College, Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7972817954 |
| Fax |
|
| Email |
hem16998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Salod, Wardha |
| Address |
Room no.30, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Salod, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and research center, Salod,Wardha. 442001, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Salod Wardha |
| Address |
Room no.30, department of Kayachikitsa,Mahatma Gandhi Ayurved College, Salod, Wardha.442001, Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hemangi Patil |
Mahatma Gandhi Ayurved College, Salod, Wardha. |
Room no.30, Department of Kayachikitsa, Mahatma Gandhi Ayurved College ,Salod, Wardha
Wardha
MAHARASHTRA |
7972817954
hem16998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Salod, Wardha, 442001, Maharashtra, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F328||Other depressive episodes. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), (2) ICD-10 Condition:F328||Other depressive episodes. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gorakhmundi vati, Reference: Kaidev nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hingvadi vati, Reference: Bhaishajya ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients which are willing to prticipate in the study and to give written informed consent.
2. Patients are selected irrespective of gender, race and religion.
3. Patients between 18-50 years of age group.
4. Patients having mild symptoms of depression i.e.having HDRS score between 8-16
5. Patients with history of depression less than one year.
6. Patients who were under meidication for depression previously but not using now. |
|
| ExclusionCriteria |
| Details |
1. Patients having any other systemic disease.
2. A lifetime history of psychotic disorder.
3. Patients under the age of 18 years and above the age of 50 years.
4. Patients with moderate to severe depression i.e.having HDRS score between 17-52
5. Pregnant women.
6. Lactating women.
7. Bipolar disorder.
8. Obsessive compulsive disorder.
9. Patients with suicidal tendency/ thoughts. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will be assessed using Hamilton Depression Rating Scale. [HDRS-17] |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The out come will be assessed using Hamilton Depression Rating Scale. [HDRS -17] |
30 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="26"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, salod(H), Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trail is a parallel group, randomized, open clinical, standard controlled trial, it will include a 30 days treatment period. |