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CTRI Number  CTRI/2023/09/057499 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 29/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Shatpushpa- Shatavari churna and Shatpushpa taila UB in Artavakshaya. 
Scientific Title of Study   A comparative clinical evaluation of shatpushpa shatavari churna and shatpushpa taila uttar vasti in the management of artava kshaya with special reference to oligohypomenorrhoea 
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 Sheetal Verma 
Designation  Research Scholar  
Affiliation  State Ayurvedic College and Hospital  
Address  PG Department of Prasuti Tantra evam Stri Rog, State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, Lucknow
PG Department of Prasuti Tantra evam Stri Rog, State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, Lucknow
Lucknow
UTTAR PRADESH
226004
India 
Phone  8957935355  
Fax    
Email  sheetalverma1408@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Sharma  
Designation  Professor  
Affiliation  State ayurvedic college and hospital Lucknow Uttar Pradesh  
Address  PG department of prasuti tantra evam stri Rog, state ayurvedic college and hospital Lucknow
Tulsidas marg turiyaganj Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India 
Phone  8795545443  
Fax    
Email  bedar.shashi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Shashi Sharma  
Designation  Professor  
Affiliation  State Ayurvedic College and Hospital Lucknow Uttar Pradesh  
Address  PG Department of Prasuti Tantra Evam Stri Rog,State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj,Lucknow
PG Department of Prasuti Tantra evam Stri Rog,State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, Lucknow
Lucknow
UTTAR PRADESH
226004
India 
Phone  8795545443  
Fax    
Email  bedar.shashi@gmail.com  
 
Source of Monetary or Material Support  
State ayurvedic college and hospital Tulsidas marg turiyaganj Lucknow Uttar Pradesh  
 
Primary Sponsor  
Name  State ayurvedic college and hospital Lucknow  
Address  Tulsidas marg turiyaganj Lucknow Uttar Pradesh  
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 Sheetal Verma   State Ayurvedic College and Hospital   Post Graduate Department of Prasuti Tantra evam Stri Rog,Room no 1, Tulsidas Marg, Turiyaganj,Lucknow 226004
Lucknow
UTTAR PRADESH 		 8957935355

sheetalverma1408@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, State Ayurvedic College and Hospital Lucknow   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Basti karma uttara basti (Procedure Reference: Charak samhita, Procedure details: Poorva karma,pradhana karma, pashchat karma. Duration- once a day for 3 alternate days for 3 consecutive cycles.)
(1) Medicine Name: Shatpushpa taila , Reference: Kashyap kalpa sthana shatpushpashatavarikalpaadhyaya 5-8, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days
2Intervention ArmDrugClassical(1) Medicine Name: Shatpushpa shatavari churna , Reference: Kashyap kalpa sthana shatpushpashatavarikalpaadhyaya 5-8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ghrita ), Additional Information: Gap of 3 days during menses
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Married patients fulfilling the cardinal symptoms of Artavakshaya.
2.Patients between the age group of 20-40 years.
3.Patients willing to participate in the study with proper written consent. 
 
ExclusionCriteria 
Details  1.Patient having systemic diseases which interfere with the present study.
2.Pregnant & Lactating women.
3.Patient on OCPs, IUCD.
4.Patient with congenital anomalies of uterus or ovaries.
5.Any other pelvic pathology or malignancy.
6.Anaemic patients (Hb less than 8 gm/dL) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of trial therapy on subjective parameters like Interval between two cycles,
Duration of Menstrual Bleeding,Amount of Menstrual blood loss & Pain during Menstruation.
 		 2 month
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of trial therapy in the management of Artavakshaya.
 		 8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/09/2023 
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="1"
Months="3"
Days="0" 
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   Title - A comparative clinical evaluation of Shatpushpa - shatavari churna and Shatpushpa taila uttarbasti in the management of Artavakshaya wsr oligo- hypomenorrhoea.
Objective - To compare the efficacy of Shatpushpa - shatavari churna orally along with Shatpushpa taila uttarbasti in the management of Artavakshaya wsr oligo-hypomenorrhoea. 
Type of study – Randomized comparative open clinical trial.
Administration of trial therapy – Minimum 40 patient having cardinal symptoms of Artavakshaya will be registered into two groups.
Group 1– This group of patients will be given the trial drug Shatpushpa- Shatavari Churna 5 gm with ghrita twice a day for 3 consecutive cycles after clearance of menses.
Group 2 – This group of patients will be given the trial drug Shatpushpa- Shatavari Churna 5 gm with ghrita twice a day along with Shatpushpa taila Uttarbasti 5 ml once a day for 3 alternate days for 3 consecutive cycles after clearance of menses.
Duration of trial – 4 consecutive cycles (3 cycles with trial drug and one cycle drug free Follow up).
Follow up during treatment – On the clearance of each menstrual cycle during the period of treatment.
CRITERIA FOR SELECTION OF PATIENT
Diagnostic Criteria-
Diagnosis will be based on the presence of any two or more of the cardinal symptoms of Artavakshaya.
A. Yathochitakala Adarshanam of Artava – Menstrual cycle > 35 days
B. Alpartavam – a) Duration of menstrual bleeding < 2 days
                             b) Decrease in quantity of menstrual blood (using 1-2 pads per day)
C. Yoni Vedana– Pain during menstruation
Inclusion criteria:
1. Married patients fulfilling the cardinal symptoms of Artavakshaya.
2. Patients between the age group of 20-40 years.
3. Patients willing to participate in the study with proper written consent.
Exclusion criteria:
1. Patient having systemic diseases which interfere with the present study.
2. Pregnant & Lactating women.
3. Patient on OCPs, IUCD.
4. Patient with congenital anomalies of uterus or ovaries.
5. Any other pelvic pathology or malignancy.
6. Anaemic patients (Hb less than 8 gm/dL)
Discontinuation Criteria:
1. Patient does not want to continue trial.
2. Aggravation of complaint
3. Any other acute illness.
Investigation: At the time of registration.
1. CBC
2. ESR
3. RBS
4. LFT
5. Thyroid profile
6. USG uterus and adnexa – TAS/TVS
7. UPT
8. LH , FSH (if needed)
ASSESSMENT CRITERIA
Assessment will be done on the basis of improvement in the sign and symptom for the purpose.
       SUBJECTIVE CRITERIA
1. Interval between two cycles.
2. Duration of Menstrual Bleeding.
3. Amount of Menstrual blood loss.
4. Pain during Menstruation.

 
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