| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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. |