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CTRI Number  CTRI/2023/01/049054 [Registered on: 17/01/2023] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, Shatavari Mulaasava and Shatavari Churna in patients suffering from Nidranasha (Insomnia) 
Scientific Title of Study   Randomised controlled clinical trial to compare the efficacy of Shatavari Mulaasava and Shatavari Churna in the management of Nidranasha. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravina Nagesh Dalvi 
Designation  PG scholar 
Affiliation  Tilak Ayurvedic Mahavidyalaya, Pune 
Address  Depatment of Swasthavritta, 2nd floor, Tilak Ayurvedic Mahavidyalaya. 583/2, Rasta peth, Pune - 11

Pune
MAHARASHTRA
411011
India 
Phone  9511847314  
Fax    
Email  anamayr2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nileema R Shisode 
Designation  Guide / Associate professor 
Affiliation  Tilak Ayurvedic Mahavidyalaya, Pune 
Address  Department of Swasthavritta, 2nd floor, Tilak Ayurvedic Mahavidyalaya 583/2, Rasta peth, Pune - 11

Pune
MAHARASHTRA
411011
India 
Phone  9422058413  
Fax    
Email  nileema.shisode7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravina Nagesh Dalvi 
Designation  PG scholar 
Affiliation  Tilak Ayurvedic Mahavidyalaya, Pune 
Address  OPD No.23, Swasthyarakshan OPD,3rd flor OPD buildng, Seth tarachand ramnath ayurvedic hospital,Vednath S marg, Rasta peth, Pune - 411011

Pune
MAHARASHTRA
411011
India 
Phone  9511847314  
Fax    
Email  anamayr2021@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital. Vednath S marg, Rasta peth, Pune - 411011 
Tilak Ayurvedic Mahavidyalaya. 583/2, Rasta peth, Pune - 411011 
 
Primary Sponsor  
Name  Dr Ravina Nagesh Dalvi 
Address  Tilak Ayurvedic Mahavidyalaya 583/2, Rasta peth, Pune - 411011 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravina Nagesh Dalvi  Swasthya rakshan OPD, Seth Tarachand Ramnath Charitable Ayurvedic Hospital  Third floor, Tarachand hosital, Vednath S marg, Rasta peth, Pune - 411011
Pune
MAHARASHTRA 		 9511847314

anamayr2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tilak Ayurvedic Mahavidyalaya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatavari mulaasava, Reference: Charak samhita sutrasthana 25/49, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: To be mixed with equal quantity of water before consumption.
2Comparator ArmDrugClassical(1) Medicine Name: Shatavari churna, Reference: Bhavaprakash nighantu - Guduchyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients suffering from Insomnia since 6 months. 2. Patients showing mild to moderate symptoms of Insomnia. 3. Patients having Insomnia severity index score between 8 to 21.  
 
ExclusionCriteria 
Details  1. Patients having history of any comorbidities along with Insomnia. 2. Patients having history of any chronic psychological conditions. 3. Pregnant and lactating mothers. 3. Patients suffering from diabetes mellitus.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Insomnia severity index score will be evaluated using Insomnia severity index scale.   After completion of 30 days of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Symptoms of Insomnia mentioned in ayurvedic text will be accessed.  After completion of 30 days of intervention. 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/02/2023 
Date of Study Completion (India) 19/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a randomized controlled clinical trial to compare efficacy of Shatavari mulaasava 15 ml daily once and Shatavari churna 1 gm daily once for 30 days in 58 patients suffering from Nidranasha or Insomnia. Trial will be conducted at the hospital attached to our institute. Outcomes will be measured on basis of Insomnia severity index score scale and accessing the symptoms of Nidranasha mentioned in ayurvedic texts.  
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