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CTRI Number  CTRI/2026/01/100444 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to evaluate the effect of Saraswatarishta and Panchakarma therapies in children with Autism. 
Scientific Title of Study   An experimental and open label clinical study to evaluate the efficacy of Saraswatarishta and Panchakarma modalities in the management of Autism among children w.s.r. to Unmada 
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 Minakshi 
Designation  Professor 
Affiliation  RGGPG Ayurvedic College and Hospital 
Address  Anatomy block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, HIMACHAL PRADESH 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418017565  
Fax    
Email  drminakshi2050@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Minakshi 
Designation  Professor 
Affiliation  RGGPG Ayurvedic College and Hospital 
Address  Anatomy block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, HIMACHAL PRADESH 176115

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418017565  
Fax    
Email  drminakshi2050@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sakshi Thakur 
Designation  PG Scholar 
Affiliation  RGGPG Ayurvedic College and Hospital 
Address  RGGPG Ayurvedic College and Hospital, Paprola, Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176115
India 
Phone  08219845717  
Fax    
Email  saakshi.thakur.7@gmail.com  
 
Source of Monetary or Material Support  
Charak Govt. Ayurvedic Pharmacy Paprola, Distt Kangra, Herbal garden and Herbarium, Research Institute in ISM, Joginder Nagar, Distt. Mandi 
 
Primary Sponsor  
Name  RGGPG Ayurvedic College 
Address  RGGPG Ayurvedic College and Hospital, Paprola, Kangra 176115 
Type of Sponsor  Research institution and hospital 
 
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 
Prof Minakshi   RGGPG Ayurvedic College, Paprola   Room no. 218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH 		 9418017565

drminakshi2050@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To study the effect of drug in management of children with autism  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: सहस्त्रयोगं , Procedure details: Matra basti with Ksheerbala taila)
(1) Medicine Name: Ksheerbala taila, Reference: सहस्त्रयोगं , Route: Rectal, Dosage Form: Taila, Dose: 24(ml), Frequency: od, Duration: 21 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: अ.सं.सू.29/30, Procedure details: Pratimarsha nasya with Brahmi ghrita)
(1) Medicine Name: Brahmi ghrita, Reference: अ.सं.सू.29/30, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 42 Days
3Intervention ArmDrugClassical(1) Medicine Name: Saraswatarishta, Reference: भै.र. ७३/१७८-१९२ , Route: Oral, Dosage Form: Arishta, Dose: 3.25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -
4Comparator ArmProcedure-Shirodhara (Procedure Reference: Dharakalpa of Sahasrayogam, Procedure details: Shirodhara with Ksheera In three sittings of 14 Days each )
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between age group of 3 to 12 years diagnosed with autism using Indian Scale
for Assessment of Autism.
Children without any acute illness or medical emergencies.
Parents of study subjects willing to participate in the trial. 
 
ExclusionCriteria 
Details  Children below 3 years of age and above 12 years of age.
Children with severe comorbidities (Epilepsy or seizure disorders etc.)
Children diagnosed with genetic conditions like Down syndrome, Rett syndrome or Fragile X syndrome.
Parents of the children not willing to participate in the trial.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fulfillment of objective and subjective criteria  90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical safety and tolerability of Saraswatarishta and Panchakarma modalities   90 Days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1/ Phase 2 
Date of First Enrollment (India)   09/02/2026 
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="0"
Months="3"
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  
I would like to publish my research trial after completion as soon as possible. A total of 20 subjects will be studied in 2 groups. 10 study subjects will be managed with Saraswatarishta and 10 study subjects will be managed with Panchakarma modalities. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools. 
 
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