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CTRI Number  CTRI/2026/03/106287 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
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 compare two Ayurvedic treatment combinations using Ashwagandha and Phalaghrita in women with infertility 
Scientific Title of Study   An open label double arm randomized clinical study to compare the efficacy of ashwagandha arka orally with phalaghrita matra basti and ashwagandha ksheerapaka orally with phalaghrita matra basti in vandhyatva w.s.r to anovulation in infertility 
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 Sneha S Shastry 
Designation  PG scholar 
Affiliation  Sri Kalbyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre 
Address  Department of PTSR Room number -209 Sri Kalbyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore 10 Pipeline road RPC layout Vijayanagar Bangalore 560104
Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India 
Phone  9113226066  
Fax    
Email  sneha.shastry2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Anupama V 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre 
Address  Department of PTSR Room number -209 Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore 10 Pipeline road RPC layout Vijayanagar Bangalore 560104
Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India 
Phone  9845442660  
Fax    
Email  dr.anupama.v@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Anupama V 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre 
Address  Department of PTSR Room number -209 Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore 10 Pipeline road RPC layout Vijayanagar Bangalore 560104
Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India 
Phone  9845442660  
Fax    
Email  dr.anupama.v@gmail.com  
 
Source of Monetary or Material Support  
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore  
 
Primary Sponsor  
Name  Dr Sneha S Shastry 
Address  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore 10 Pipeline road RPC layout Vijayanagar Bangalore 560104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sneha S Shastry  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre  Department of PTSR Room number -209 Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore 10 Pipeline road RPC layout Vijayanagar Bangalore 560104
Bangalore
KARNATAKA 
9113226066

sneha.shastry2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandha Arka, Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Ksheera), Additional Information: Along with phala ghrita matra basti ashwagandha arka orally is given
2Comparator ArmDrugClassical(1) Medicine Name: Ashwagandha Ksheerapaka, Reference: Yogaratnakara, Route: Oral, Dosage Form: Ksheerpaka, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Along with pahala ghrita matra basti ashwagandha ksheerapaka will be given orally
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Subjects between the age group 20–40 years
Subjects with regular and irregular menstrual cycle
Subjects diagnosed with Polycystic Ovarian Disorder
Subjects diagnosed with primary and secondary infertility due to Anovulation
 
 
ExclusionCriteria 
Details  Patients with any systemic disorders which interfere with the course of treatment.
Patients diagnosed with premature ovulation failure, resistant ovarian syndrome.
Anatomical and developmental defects of ovary
 
 
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 
To evaluate the induction of ovulation, assessed through follicular growth and rupture by follicular study from Day 12 of each menstrual cycle on alternate days until ovulation for 2 consecutive treatment cycles during a 3-month study period in the women with Vandhyatva w.s.r to anovulation in infertility to compare efficacy of 2 formulations of Ashwagandha (Ashwagandha Arka or Ashwagandha Ksheerapaka) combined with Phala Ghrita Matra Basti, in stimulating ovulation.
 
1year 6months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  not applicable 
 
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 2 
Date of First Enrollment (India)   24/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="3" 
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  

Infertility is a significant global health concern, affecting nearly 17.5% of the adult population, with anovulation accounting for about 30% of female infertility cases. Anovulation occurs due to disturbance in the hypothalamic–pituitary–ovarian axis, often influenced by improper diet, lifestyle, and stress, leading to failure of ovum release. In Ayurveda, infertility is termed Vandhyatva, which includes both failure to conceive and inability to sustain pregnancy, and is mainly attributed to Apana Vata dushti and Artava kshaya. Successful conception depends on the proper functioning of Rutu, Kshetra, Ambu, and Beeja, and impairment of Beeja results in Nashtartava (anovulation).

Conventional ovulation-inducing drugs may cause adverse effects such as reduced ovarian reserve, whereas Ayurveda offers safer alternatives. Ashwagandha (Withania somnifera), a potent Rasayana and Balya drug, has shown beneficial effects on ovarian function, folliculogenesis, and hormonal balance. Ashwagandha Arka is considered more potent due to its method of preparation, while Ashwagandha Ksheerapaka is traditionally used in reproductive disorders. Phalaghrita Matra Basti acts on Apana Vata and supports uterine and ovarian functions. Hence, a comparative clinical study is proposed to evaluate the efficacy of Ashwagandha Arka and Ashwagandha Ksheerapaka along with Phalaghrita Matra Basti in anovulatory infertility.

 
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