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CTRI Number  CTRI/2024/10/074549 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 07/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study to Test the Effect of Gradually Increasing Doses of Gokshuradi Taila Enema in Treating Anovulation. 
Scientific Title of Study   A Clinical Study to Evaluate the Effect of Arohana Anuvasan Basti with Gokshuradi Taila in the Management of Anovulation 
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 SWATHI C 
Designation  Associate professor, M.S. (Ayu) Dept. of PG Studies in Prasuti Tantra Evam Striroga 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of prasuti tantra Evam stri roga,First Floor,Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu

Thiruvallur
TAMIL NADU
600123
India 
Phone  8105774944  
Fax    
Email  drswathi@sjsach.org.in  
 
Details of Contact Person
Scientific Query  
Name  DR SWATHI C 
Designation  Associate professor, M.S. (Ayu) Dept. of PG Studies in Prasuti Tantra Evam Striroga 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of prasuti tantra Evam stri roga,First Floor,Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu

Thiruvallur
TAMIL NADU
600123
India 
Phone  8105774944  
Fax    
Email  drswathi@sjsach.org.in  
 
Details of Contact Person
Public Query  
Name  DR GONDHANE MAYURI RAMKRUSHNA 
Designation  2nd year PG Scholar, Dept. of PG Studies in Prasuti Tantra Evam Striroga 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of prasuti tantra Evam stri roga,First floor,Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu

Thiruvallur
TAMIL NADU
600123
India 
Phone  8275485111  
Fax    
Email  mayurigondhane9796@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu. 
 
Primary Sponsor  
Name  DrGondhane Mayuri Ramkrushna  
Address  Dept of PG Studies in Prasuti Tantra Evam Striroga Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
DR SWATHI C  Dept. of PG Studies in Prasuti Tantra Evam Striroga Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SWATHI C  Sri Jayendra Saraswathi Ayurveda Hospital  Dept of PG Studies in Prasuti Tantra Evam Striroga, First floor, Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295,Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu.
Thiruvallur
TAMIL NADU 		 8105774944

drswathi@sjsach.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital ,Department of Ayurveda,SCSVMV,Nazarathpet ,Chennai,600123  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: VANDH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Nirmal Saxena. Cikitsasara Samgraha of Vangasena, Varanasi: Chowkhamba Sanskrit studies, Vol.2, Bastikarmadhikara 83/ 21-4.p. 1147, Procedure details: arohana anuvasan basti will be given under a sterilized environment according to standards of procedure)
(1) Medicine Name: saindhav, Reference: Nirmal Saxena. Cikitsasara Samgraha of Vangasena, Varanasi: Chowkhamba Sanskrit studies, Vol.2, Bastikarmadhikara 83/ 21-4.p. 1147, Route: Rectal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 9 Days
(2) Medicine Name: shatapushpa, Reference: Nirmal Saxena. Cikitsasara Samgraha of Vangasena, Varanasi: Chowkhamba Sanskrit studies, Vol.2, Bastikarmadhikara 83/ 21-4.p. 1147., Route: Rectal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1)Primary and Secondary both types of infertile patients having anovulation.
2)Patient eligible for Anuvasan Basti. 
 
ExclusionCriteria 
Details  1)Female patients having age less than 20 years and more than 45 years
2)Congenital deformities of reproductive tract
3)Sexually transmitted diseases (HIV, HBsAg, VDRL)
4)Patient with vaginal and cervical infection.
5)Hyperprolactinemia / Hypothyroidism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OBJECTIVE
To evaluate the therapeutic efficacy of Gokshuradi Taila Anuvasana Basti in Arohana Matra in anovulation 		 9 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OBJECTIVE
1)To evaluate the therapeutic efficacy of Gokshuradi Taila Anuvasan Basti in Arohana Matra on endometrial thickness.
2)To evaluate the therapeutic efficacy of Gokshuradi Taila Anuvasan Basti in Arohana Matra on endometrial pattern. 		 9 DAYS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   11/10/2024 
Date of Study Completion (India) 24/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 This study has been formally published as: "Rectal Administration of Diosgenin- and Gingerol-Standardised Gokshuradi Taila Induces Ovulation and Improves Endometrial Receptivity in Women with Pharmacologically Refractory Anovulatory Infertility: A Prospective Single-Arm Exploratory Study" in the International Journal of Research and Analytical Reviews (IJRAR), May 2026, Volume 13, Issue 2, Pages 478–487, Article ID IJRAR26B3106, E-ISSN: 2348-1269, P-ISSN: 2349-5138. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The global incidence rate of infertility is 17.5%.1 In India, the prevalence rate of infertility ranges from
10-14%, according to the Indian Society of Assisted Reproduction (ISAR). The most common cause
of infertility is the anovulatory factor.2 Globally, 30-40%3of infertility cases are due to anovulation,
while in India, it is around 30%.4 Ovarian factors that contribute to infertility include anovulation or
oligo-ovulation and luteinized unruptured follicle.5 LH and FSH play a very important role in the
process of ovulation. So, if there are any variations in them then it leads to anovulation. In Ayurveda,
this condition can be compared to Abeejotsarga or Artavayukta Beejadushti, which is mainly caused
by a disturbance in the Vyana Vayu and Apana Vayu. The function of Vyana Vayu is Gati, which may
regulate the activity of FSH and LH.6 Similarly, Shukra Artava Utpatti and all reproductive activities
of the body are governed by Apana Vayu.7 Any disturbances in Vata may lead to conditions like
Alpapushpa, Nashtapushpa, and Nashtabeeja,8 wherein Rutu, Kshetra, Ambu, and Beeja9 are the most
important factors. Therefore, Anuvasana Basti is mentioned as the main line of treatment for conditions
like these.10 Basti administered in increasing doses is expected to promote folliculogenesis through
Bruhana Karma. Gokshuradi Taila, if administered in the form of Basti, acts as a “Vandhyanam
Garbhajananam”.11 It contains Gokshura, Adraka, Gudam, Tila Taila, Godugdha.12 These drugs mainly
possess the properties like Madhura Rasa, Guru-Snigdha-Tikshna Guna, and Vata-Kaphahara, which
lead to an impact over folliculogenesis. Considering all the above factors, it may help the ovulation
process by virtue of controlling the vitiated Vata Dosha, therefore, it is hypothesized that Gokshuradi
Taila administered in Arohana Krama of Anuvasana Basti may be beneficial in correcting the ovulation
process. Therefore, a current study entitled “A clinical study to evaluate the effect of Arohana Anuvasan
Basti with Gokshuradi Taila in the management of anovulation” is planned.
This was a single-arm, open-label clinical study conducted on 40 female patients aged 20-35 years diagnosed with anovulatory infertility. Recruitment began on 11 October 2024 and was completed on 09 April 2025. Each participant received Arohana Anuvasana Basti with Gokshuradi Taila for 9 consecutive days, with the final procedure completed on 18 April 2025. Based on final data analysis, 35 patients (87.5%) showed complete remission (confirmed ovulation with favorable endometrial features), 4 patients (10%) showed clinical improvement, and 1 patient (2.5%) showed no change. Notably, one patient achieved confirmed conception, supported by positive urinary pregnancy test and serum beta-hCG report. No adverse events were reported.
The results are incorporated into the thesis and are under consideration for publication


 
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