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CTRI Number  CTRI/2026/02/104748 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Nasya therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Shivalingi Seed Powder and Shivalingi Oil Nasya in Women with Anovulatory Cycles 
Scientific Title of Study   A comparative experimental and clinical study on efficacy of Shivalingi Beeja Churna and Shivalingi Beeja Taila Nasya in anovulatory cycle. 
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 Kiran Parmar 
Designation  Junior Resident 
Affiliation  Banaras Hindu University  
Address  Department of Prasuti tantra Faculty of Ayurveda IMS BHU Varanasi
varanasi , Uttar Pradesh, 221005
Varanasi
UTTAR PRADESH
221005
India 
Phone  8980166199  
Fax    
Email  drkiranparmar7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Deepa Mishra 
Designation  Professor and Head of Department 
Affiliation  Banaras Hindu University 
Address  Department of Prasuti tantra Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  09650453095  
Fax    
Email  deepa1971mishra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Deepa Mishra 
Designation  Professor and Head of Department 
Affiliation  Banaras Hindu University 
Address  Department of Prasuti tantra Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  09650453095  
Fax    
Email  deepa1971mishra@gmail.com  
 
Source of Monetary or Material Support  
Sir Sundarlal Hospital Faculty of Ayurveda Institute Of medical Science BHU Varanasi 221005 Uttar Pradesh 
 
Primary Sponsor  
Name  Sir Sundarlal Hospital Faculty of Ayurveda IMS BHU Varanasi 
Address  OPD NO 24 Prasuti Tantra OPD Department Of Prasuti Tantra Faculty of Ayurveda Institute of Medical science Banaras Hindu University Varanasi 221005 Uttar Pradesh 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 Kiran Parmar   Sir Sundarlal Hospital BHU  Department of Prasuti tantra Faculty of Ayurveda IMS BHU Varanasi varanasi , 221005
Varanasi
UTTAR PRADESH 		 8980166199

drkiranparmar7@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:N970||Female infertility associated withanovulation. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: sushruta samhita chikitsa sthan 40/42, Procedure details: Patient should be given Abhyanga (massage) with any oil and Swedana (steaming) with luke warm water over the face. The patient will be made to lie in supine position extending her arms and legs, head is slightly extended up to 45 degrees. Later the tip of nose is drawn upward by Vama Pradeshini (left index finger) and with right hand the lukewarm Shivalingi beeja taila 6 drops in each nostril will be instilled for consecutive 7 days (after clearance of menses ) for 2 consecutive cycles. )
(1) Medicine Name: shivalingi beeja taila , Reference: Raj nighantu Guduchyadi varga , Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 7 Days
2Comparator ArmDrugClassical(1) Medicine Name: shivalingi beeja , Reference: Raj nighantu Guduchyadi varga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Go dugdha), Additional Information: 4 gms bd shivalingi beeja churna given for 30 days for 2 consecutive cycles
3Intervention ArmDrugClassical(1) Medicine Name: shivalingi beeja churna, Reference: Raj nighantu Guduchyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Go dugdha), Additional Information: 4 gms bd shivalingi beeja churna given for 30 days for 2 consecutive cycles
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Diagnosed cases of anovulation or at least 2 consecutive anovulatory cycles. 
 
ExclusionCriteria 
Details  Pregnant women
Lactating women
Active cases of HIV, HBsAg, Anti HCV.
Women on oral contraceptive pills ,anti-androgen, ovulation induction medicines or other hormonal treatment.
Women with severe sinusitis, nasal polyp, nasal tumor, D.N.S.( Deviated nasal septum) Patient with any systemic debilitating disease and malignancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in irregularity of menstrual cycle if there
Significant improvement in hormonal imbalance if there
 		 2 regular follow ups with interval of 30 days with medicines and 1 follow up without medicine 
 
Secondary Outcome  
Outcome  TimePoints 
Significant improvement in irregularity of menstrual cycle if there
Significant improvement in hormonal imbalance if there
 		 Before treatment
And after 60 days of treatment hormonal profile will be done  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   10/03/2026 
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="1"
Months="6"
Days="5" 
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  
Anovulation often happens due to a hormone imbalance. Since multiple hormones contribute to ovulation, there can be many causes of anovulation. Anovulation is one among the major factors contributing  to infertility in women. Menstruation is unrelated to ovulation and anovular menstruation is quite common during adolescence, following childbirth and in women approaching menopause  and can also be associated with conditions like PCOS (Polycystic ovarian syndrome) ,POI (Primary Ovarian Insufficiency ) and DOR (Decreased ovarian reserve).
According to Ayurvedic perspective , Anovulatory cycle can be considered a disorder of vata kapha pradhana tridosha (principal constituent of body )  and Dhatudushti  (vitiation of fundamental body tiisues ) of rasa ,rakta and also srotas (functional channel ) involved are rasavah (plasma carrying channel)  , raktavah (blood carrying channel) and artavavaha srotas  (channels carrying menstrual blood ) which eventually manifest symptoms like anartava / artavakshaya ( oligomenorhhea / amenorrhea ) , vandhyatwa (infertility) . In present trial Shivalingi Beeja Churna orally is compared with Shivalingi Beeja Taila Nasya in diagnosed patients of anovulatory cycle.  
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