| CTRI Number |
CTRI/2026/02/104047 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to find out how Mandukparni Churna helps in reducing anxiety Generalized Anxiety Disorder |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF
MANDUKPANRNI CHURNA IN THE MANAGEMENT OF CHITTODVEGA WITH
SPECIAL REFERENCE TO GENERALIZED ANXIETY DISORDER (GAD) |
| 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 Tanvi Rajesh Hundekar |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422402
India |
| Phone |
9637576884 |
| Fax |
|
| Email |
tanvihundekar8421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiraman Warungase |
| Designation |
HOD and professor |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422402
India |
| Phone |
9420364157 |
| Fax |
|
| Email |
hiramanwarungase@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvi Rajesh Hundekar |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422402
India |
| Phone |
9637576884 |
| Fax |
|
| Email |
tanvihundekar8421@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tanvi Hundekar |
| Address |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK 422402 |
| Type of Sponsor |
Other [Self] |
|
|
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 Tanvi Rajesh Hundekar |
SMBT AYURVED COLLEGE AND HOSPITAL |
Department of Kayachikitsa
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA |
09637576884
tanvihundekar8421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Tanvi Rajesh Hundekar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mandookaparni Churna, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Goghrit), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shankhapushpi churna, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Goghrit), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ICD-10GeneralisedAnxiety Disorder7
According to ICD10Diagnostic Criteria Patient are selected. (International Classification
of Disease )
A period of at least six months with prominent tension, worry and feelings of
apprehension ,about every day events and problems.
Patients with the score in range between 13 to 24 on Hamilton Anxiety rating scale( mild)
and (moderate)
Age between 18 to 50 years |
|
| ExclusionCriteria |
| Details |
History of anxiety and worry for less than 6 months.
Patient with suicidal tendency.
Patients with the score in range above 18 on Hamelton Anxiety rating
scale[Moderate and severe]
Patient suffering from other psychiatric illness like mood disorder,epilepsyetc.
Obsessive compulsive disorder.
Having major systemic illness.
Secondary GAD due to systemic conditions like uncontrolled DM,
Hypertension,Hyperthyroidism, Cardiac disorders, deficiency status, neurological
disorders and miscellaneous conditions.
Socialphobia.
Drugabuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the effect of Mandukparni choorna in Chittodvega with special reference
to Generalised Anxiety Disorder (GAD) on the basis of subjective and objective
parameterafter1month of treatment duration. |
0 , 15 , 30 th day 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
09/03/2026 |
| 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="6"
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
|
Title- A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF
MANDUKPANRNI CHURNA IN THE MANAGEMENT OF CHITTODVEGA WITH
SPECIAL REFERENCE TO GENERALIZED ANXIETY DISORDER (GAD) Ayurveda views health as a balanced state of body, mind, senses, and soul, similar to the WHO concept of complete well-being. Chittodvega is a mental disorder described in Ayurveda that closely resembles Generalized Anxiety Disorder and arises due to imbalance of mental doshas (Rajas and Tamas). Ayurveda treats such conditions through a psychosomatic approach focusing on restoring mental and physical balance NullHypothesis[H0]: Mandukparni choorna is not effective in the management of
Chittodvega with special reference to Generalised Anxiety Disorder(GAD). AlternateHypothesis[H1]:-Mandukparni choorna is effective in the managemen tof
Chittodvega with special reference to Generalised Anxiety Disorder(GAD).
|