| CTRI Number |
CTRI/2025/07/090769 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The efficacy of Shalaparni Churna in management of Generalized Anxiety Disorder in Adults |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial Of Medhya Effect Of Shalaparni (Desmodium gangeticum (L.) DC) Churna With Ashwagandha (Withania somnifera (L.) Dunal) Churna In Anavasthita Chitta In Perspective Of Generalized Anxiety Disorder in Adult Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Shivangi Vinay Bodas |
| Designation |
P.G. Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Dravyaguna, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9130014228 |
| Fax |
|
| Email |
shivangibodas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asmita U Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Dravyaguna, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9359772607 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita U Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Dravyaguna, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9359772607 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Sheth Tarachand Ramnath Charitable Ayurved Hospital, Rasta Peth, Pune |
|
|
Primary Sponsor
|
| Name |
Vd. Shivangi Bodas |
| Address |
Tilak Ayurved Mahavidyalaya and Sheth Tarachand Ramnath Charitable Hospital, Rasta Peth, Pune 411011 |
| 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 |
| Vd Shivangi Bodas |
Tilak Ayurved Mahavidyalaya and Sheth Tarachand Ramnath Charitable Ayurved Hospital |
OPD no.27, 4th floor, Sheth Tarachand Ramnath Charitable Ayurved Hospital, Rasta Peth, Pune 411011
Pune
MAHARASHTRA |
9130014228
shivangibodas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of CPGSRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: ANAVASTHITACITTATVAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shalaparni Churna, Reference: Ashtang hridaya uttarsthana 39/60-61, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Dugdha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Churna, Reference: Ashtang hridaya uttarsthana 39/60-61, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Dugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be selected irrespective of gender with age between 20-40 years, fulfilling
criteria for generalized anxiety disorder given in the Diagnostic and Statistical Manual of
Mental Disorders.
|
|
| ExclusionCriteria |
| Details |
Participants with known case of any serious illness (cardiac, hepatic, renal disease,
respiratory disorder, cancer etc.)
Participants with known case of Mental retardation or having any other psychiatric
treatment
Pregnant or lactating woman |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the symptoms of anxiety and reduction of score (HAM-A Scale) by 50% or more |
Every 15 days for 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating any other effect of shalaparni clinically |
2 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/08/2025 |
| 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="2"
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
|
The primary objective of this open-labelled, randomized controlled clinical trial is to assess the effect of Shalaparni (Desmodium gangeticum (L.) DC) churna with respect to Ashwagandha churna for the management of Anavasthita Chitta in perspective of Generalized Anxiety Disorder. The secondary objectives are:
-
To collect a genuine sample of Shalaparni (Desmodium gangeticum (L.) DC) and to study its pharmacognostic and physicochemical properties.
-
To study the cultivation practices of Shalaparni and to cultivate it as per feasibility.
A total of 46 participants between the ages of 20 and 40 years, having moderate to severe anxiety as per the GAD-7 scale, will be selected for the study. They will be randomly allocated into two groups. Participants in Group A will receive the study drug, i.e., Shalaparni churna, and participants in Group B will receive the control drug, i.e., Ashwagandha churna.
Assessment will be carried out using the Hamilton Anxiety Rating Scale (HAM-A) at the beginning of the study. Participants will then receive the respective drugs, to be taken for a duration of two months. Reassessment using the HAM-A scale will be conducted at the end of two months. An improvement of 50% or more in the HAM-A score will be considered significant. |