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CTRI Number  CTRI/2025/02/080598 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Basti therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effects of Shatavari and Nirgundi on Anovulation and Endometrial Health 
Scientific Title of Study   An Analytical and Comparative Study Between Shatavari and Nirgundi in Anovulation and Endometrial Expression Profiling  
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 Powar Padmja Parashram 
Designation  MS scholar 
Affiliation  Banaras Hindu University 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  09172444030  
Fax    
Email  padmjapowar98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Sunita Suman 
Designation  Professor and formar HOD 
Affiliation  Banaras Hindu University 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7607165096  
Fax    
Email  ssom18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Sunita Suman 
Designation  Professor and formar HOD 
Affiliation  Banaras Hindu University 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7607165096  
Fax    
Email  ssom18@gmail.com  
 
Source of Monetary or Material Support  
Sir Sundarlal Hospital Faculty of Ayurveda Institute of medical science Banaras Hindu University varanasi 221005 Uttarpradesh India  
 
Primary Sponsor  
Name  Faculty of Ayurveda Institute of Medical Sciences BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda IMS BHU Varanasi Uttarpradesh 221005 India  
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 
Dr Powar Padmja Parashram   Sir Sunderlal Hospital BHU  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH 		 09172444030

padmjapowar98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banaras Hindu University Institute of Medical Science Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: A H Su 19/81-82, Procedure details: Under all aseptic precautions intrauterine instillation of medicated oil in the dose of 3-5 ml will be done for 3 consecutive days (after clearance of menses) followed by gap of 3 days and again same procedure will be repeated for 3 days for 3 consecutive cycles (6 uttarabasti/cycle))
(1) Medicine Name: Nirgundi Taila , Reference: Cha Chi 28/135, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Months
2Comparator ArmDrugClassical(1) Medicine Name: Shatavari Churna, Reference: Ka S K 5/7-10, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Go ghrita), Additional Information:
3Intervention ArmDrugClassical(1) Medicine Name: Nirgundi Churna , Reference: Dhanwantari Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: -
4Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: A H Su 19/81-82, Procedure details: Under all aseptic precautions intrauterine instillation of medicated oil in the dose of 3-5 ml will be done for 3 consecutive days (after clearance of menses) followed by gap of 3 days and again same procedure will be repeated for 3 days for 3 consecutive cycles (6 uttarabasti/cycle))
(1) Medicine Name: Shatavari Taila, Reference: Ka S k 5/7-10, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married women
Patients with 2 consecutive anovulatory cycles. 
 
ExclusionCriteria 
Details  Unmarried patients
Patient having like organic pelvic pathology, benign and malignant tumours (Vulval, vaginal, rectal, cervical, uterine, ovarian), PID, congenital anomalies of genital tract and different type of infections of genital tract.
Patient suffering from chronic systemic diseases like uncontrolled hypertension, uncontrolled diabetes or any disorders influencing the general physical health and ultimately influencing menses.
Patients using IUCD and OCPs or injectable contraceptives & others.
Patients diagnosed with venereal diseases like syphilis, Gonorrhoea, HIV, HBsAg etc.
Patient is on chemotherapy/radiotherapy for malignant condition of the breast or any other organ.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Based on Subjective and objective parameters and laboratory investigations
A Subjective Criteria
Characteristics of menstruation
Intermenstrual period
Duration of menstrual bleeding
Amount of blood loss

B Objective criteria
Size and maturity of follicles/ovulation
Viscosity of cervical mucus
Hormonal profile
Serum Progesterone (on D 8 & 21),
Serum LH (midcycle daily)
Serum FSH (D2/3)
Serum Estradiol (D2/3)
Serum Prolactin
Serum Testosterone
Serum AMH
Serum Cortisol (morning 7-8 am)
Biochemical characterization of endometrium.
Applebaum’s Uterine Scoring System for Reproduction (USSR) 		 Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle  
 
Secondary Outcome  
Outcome  TimePoints 
Ovulation will be observed in the patients of anovulatory cycle   3 follow ups will be done with medication at the regular interval of one month or duration & interval of her cycle & last follow up will be done without medication after 3rd cycle of uttara basti
Result will be assessed after 3 cycle of uttar basti 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/03/2025 
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="1"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

Anovulation is the failure of the ovary to produce an ovum. Technically anovulation refers to the absence of ovulation; however, some women ovulate infrequently. Anovulation or ovulatory dysfunction is most common cause of infertility which is about   30-40%. as per FIGO and, it is also possible cause of PCOS (Poly Cystic Ovarian Syndrome) due to hormonal imbalance. Hormones i.e. LH, FSH, oestrogen, Progesterone, prolactin, AMH, TSH and hypothalamo-pituitary ovarian axis play an important role in a complex procedure of ovulation but any alteration or imbalance between all these may lead to anovulation. The clinical features of anovulation resemble with symptoms of ‘beejadushti’ i.e. beejopaghata (destruction of sperm or ovum) and pushpopaghata (destruction of menstrual blood or ovum). In Ayurvedic texts, the information related to anovulation is found in scattered form.



 
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