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CTRI Number  CTRI/2023/07/055219 [Registered on: 14/07/2023] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial on Ayurvedic formulation in the management of beejadushti janya stree vandhyatwa w.s.r. to Infertility due to anovulation.  
Scientific Title of Study   A randomized comparative clinic trial to evaluate the efficacy of vatyapushpi beeja churna and amogha churna along with ashwagandha ghrita orally in beejadushti janya stree vandhyatwa. 
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 Suman kumari 
Designation  Ms scholar 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA JAIPUR 
Address  DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA, NATIONAL INSTITUTE OF AYURVEDA (DEEMED TO BE UNIVERSITY) JORAWAR SINGH GATE, JAIPUR, RAJSTHAN-302002

Jaipur
RAJASTHAN
302002
India 
Phone  9416375747  
Fax    
Email  dr.sumanshagun@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HETAL H DAVE  
Designation  ASSOCIATE PROFFESOR 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA JAIPUR 
Address  DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA, NATIONAL INSTITUTE OF AYURVEDA (DEEMED TO BE UNIVERSITY) JORAWAR SINGH GATE, JAIPUR, RAJSTHAN-302002

Jaipur
RAJASTHAN
302002
India 
Phone  9251758867  
Fax    
Email  hetaldave2406@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr HETAL H DAVE  
Designation  ASSOCIATE PROFFESOR 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  DEPARTMENT OF PRASUTI TANTRA Evam STRI ROGA, National Institute of Ayurveda, Deemed to be University (De-novo) Jorawer Singh Gate, Amer Road, Jaipur(Raj.)-302002

Rajsamand
RAJASTHAN
302002
India 
Phone  9251758867  
Fax    
Email  hetaldave2406@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, JAIPUR 
 
Primary Sponsor  
Name  National Institute of Ayurveda  
Address  National Institute of Ayurveda, Deemed to be University, Jorawar singh gate, Amer Road, Jaipur, Rajasthan 302002  
Type of Sponsor  Government medical college 
 
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 Suman Kumari  Opd and Ipd of Department of Prasuti tantra evam stree roga, National Institute of Ayurveda,Jaipur  OPD AND IPD of National Institute of Ayurveda, Deemed to be University, Jaipur, Rajasthan, 302002
Jaipur
RAJASTHAN 		 9416375747

dr.sumanshagun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS 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: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: VATYAPUSHPI BEEJA CHURNA, Reference: Charaka Samhita, sutrasthan 4/49, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: with luke warm water), Additional Information: -
(2) Medicine Name: ASHWAGANDHA GHRITA, Reference: Gad nigrah bandya adhikar (5/1), Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: with milk), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: AMOGHA CHURNA , Reference: Charaka Samhita, sutrasthan 4/49,, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: with luke warm water), Additional Information: -
(2) Medicine Name: ASHWAGANDHA GHRITA, Reference: Gad nigrah bandya adhikar (5/1), Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: with milk), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Anovulation (beejadusti) on folliculometry was verified in all cases of primary and Secondary stree Vandhyatwa 2. Age group between 21 to 40 years
3. At least one fallopian tube must be patent. 
 
ExclusionCriteria 
Details  1.Congenital anatomical deformities of reproductive tract like bicornuate uterus,etc.
2.Bilateral tube blockage.
3.Reproductive tract abnormalities i.e.-cervical stenosis, fibroid uterus, cervical polyp.
4.Patient suffering from severe infection and any systemic disorder like Tuberculosis, Cardiacdisorder, DiabetesMellitus, Renal disorder, Bronchial Asthma.
5. Patient suffering from HIV,VDRL.
6. Infertility due to male partner abnormality. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome:-1. Changes in the anovulation.
2. To achievement of the conception. 		 8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome :-1. Changes in the duration & interval of menses.
2.Prevalance of anovulation in different type of Prakriti. 		 8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   25/07/2023 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

 NEED OF STUDY:-In the present time vandhyatwa has been one of the unsolved major complaints of the couples. In allopathic system of medicine scope of medicinal treatment is very narrow. Hormonal therapy like- In vitro fertilization (IVF), Embryo transfer (ET), Gamete Intra fallopian transfer (GIFT) etc. So many therapies are developed but they have no satisfactory results. They are very expensive and have lots of side effects.On the other hand, Ayurveda offers a lots of potential for treating stree vandhyatwa. A number of studies have been carried out of drugs like - Shatavari, Satpushpa, Kumari, Gokshur, Phalghrita,Brahmi ghrita, Pippliyadi churna, Dasmool kwath etc. to determine their role in the treatment ofVandhyatwa .There are many such drugs mentioned in ayurveda classics heaving remarkable resultsin the management of Vandhyatwa which need to be studies further in detail. Amongst these drugs Vatyapushpi beeja churna, Amogha churna and Ashwagandha ghrita are choosen in this study. The properties of Vatyapushpi beeja is prajasthapan, garbhasyaposhan, vrishya and vatasanshman. Properties of Amoga is prajasthapan, vatasansman and properties of Ashwagandha ghrita is dhatuvardhana, garbhasandhank, vrishya, rasayana, vatasanshman. They are easily available, easy to administer, cost effective for the management of beejaduhstijanya stree vandhyatwa. So with all these considerations in mind the current study is undertaken.

NULL HYPOTHESIS: There is no difference in the efficacy of oral administration of Vatyapushpibeeja churna with Ashwagandha  ghrita and Amogha churna with Ashwagandha ghrita in Beejadushtijanya stree Vandhytwa. ALTERNATIVE HYPOTHESIS:- There is  difference in efficacy of Vatyapushpi beeja churna with Ashwagandha ghrita and Amogha churna with Ashwagandha ghrita in management of Beejadushtijanya stree Vandhytwa. RESEARCH QUESTION:-Is there any difference in the efficacy of Vatyapushpi beeja  churna with Ashwagandha ghrita   and  Amogha churna with Ashwagandha ghrita in  management of Beejadushtijanya stree Vandhytwa? AIM:-To evaluate the efficacy of Vatyapushpibeeja churna and Amogha churna along with Ashwagandha ghrita orally in Beejadushtijanya stree Vandhyatwa. 

 Primary objective:-

 To evaluate and  compare  the clinical  efficacy  of Vatyapushpi beeja churna and Amogha  churna along with  Ashwagandha ghrita to changes in the  anovulation and conception  in the mangemant of Beejdushti janya stree vandhyatwa

 Secondary objective:-

 (1)   Changes in the duration and interval of menstrual cycle.

 (2)   Prevalence of anovulation in different types of prakriti. STUDY DESIGN:-

 1. Study type–Randomized clinical trial.2. Masking–Open label. 3. Level of study–OPD and IPD level.

 5.No of group–Two groups. Group A–Vatyapushpi Beeja churna with Ashwagandha ghrita.  GroupB–Amogha churna with Ashwagandha ghrita

 6 Samplesize–15patient in each group. 6 Primary purpose–Treatment. 7 Endpoint–Efficacy. 8 Method of generating randomization sequence –Computer generated

 Primary Outcome: 1. Changes in the anovulation 2. To achievement of the conception.

Secondary Outcome 1. Changes in the duration and interval of menses. 2. Prevalance of anovulation in different type of Prakriti.

INCLUSION CRITERIA:-

1. Anovulation (beejadusti) on folliculometry was verified in all cases of primary and Secondary stree Vandhyatw 2. Age group between 21 to 40 yea 3. At least one fallopian tube must be patent.

EXCLUSION CRITERIA: 1. Congenital anatomical deformities of reproductive tract like bicornuate uterus,etc. 2. Bilateral tube blockage.3. Reproductive tract abnormalities i.e.-cervical stenosis, fibroid uterus, cervical polyp.4. Patient suffering from severe  infection and any systemic disorder like Tuberculosis,

      Cardiacdisorder, DiabetesMellitus, Renal disorder, Bronchial Asthma.5. Patient suffering from HIV,VDRL.6. Infertility due to male partner abnormality.

 WITHDRAWAL CRITERIA:-

 1. During the course of trial if any serious condition   occurs that require urgent treatment.2. Non compliance and irregular follow up.3. Patient wants to withdraw from the clinical trial.

 INVESTIGATION:-BEFORE TREATMENT(1) Complete blood test–CBC.1) ESR–Erythrocytes Sedimentation rate.(2) Hepatitis B surface Antigen (HBsAg).

(3) HIV–Human Immuno deficiency Virus.(4) VDRL-Venereal disease research laboratory. (5) Thyroid function test (TFT),T3,T4,TSH. (6) Random blood sugar (RBS).

(7) Cervical mucus (i)Spinnbarkeit test (ii)Fern test. (8) USG–Uterus and adnexa & Follicular study. HSG–Hysterosalpingography

 AFTER TREATMENT:-(1) Cervical mucus-(a) Spinnbarkeit test (b) Fern test(2) USG– Follicular study. 3) UPT-Urine pregnancy test if necessary.

 


 
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