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CTRI Number  CTRI/2025/01/079006 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Zandu Nityam tablet and Zandu Nityam churna 
Scientific Title of Study   Evaluation of the safety & efficacy of Zandu Nityam Tablet incomparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation : A RCT 
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. Pragati Ashok Katariya 
Designation  Professsor and Hod, dept of kayachikitsa 
Affiliation  Shri Dhanwantry Ayurvedic college and hospital, Chandigarh 
Address  Room no. 109 OPD of Kayachikitsa department, Shri Dhanwantry ayurvedic college and hospital, sector 46-B, Chandigarh, 160047

Chandigarh
CHANDIGARH
160047
India 
Phone  7814144288  
Fax    
Email  pragatidr5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Shrivastava 
Designation  Principal 
Affiliation  Shri Dhanwantry Ayurvedic college and hospital, chandigarh 
Address  Principal office, Academic Block, Shri Dhanwantry ayurvedic college and hospital, sector 46-B, Chandigarh, 160047

Chandigarh
CHANDIGARH
160047
India 
Phone  7986502791  
Fax    
Email  sumitpankaj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaidya Kanika Aggarwal 
Designation  Professor department of Panchkarma 
Affiliation  Shri Dhanwantry ayurvedic college and hospital, chandigarh 
Address  Room no. 110, OPD of Panchkarma department, Shri Dhanwantry ayurvedic college and hospital, sector 46-B, Chandigarh, 160047

Chandigarh
CHANDIGARH
160047
India 
Phone  8360282161  
Fax    
Email  kanikaaggarwal1986@gmail.com  
 
Source of Monetary or Material Support  
Emami limited, Emami Tower 687 Anandapur, EM Bypass Kolkata 700107 West Bengal, INDIA 
 
Primary Sponsor  
Name  Emami limited , Kolkata 
Address  Emami tower, 687. Anandapur, EM Bypass, Kolkata, 700107, West Bengal 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Pragati Ashok Katariya  Shri Dhanwantry Ayurvedic college and hospital, chandigarh  Room no. 109 OPD of Kayachikitsa department, Shri Dhanwantry ayurvedic college and hospital, sector 46 B, chandigarh 160047
Chandigarh
CHANDIGARH 
7814144288

pragatidr5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Shri Dhanwantry ayurvedic college and hospital chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: MALA-APRAVRUTIH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Zandu Nityam Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Zandu Nityam Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of Functional constipation, fulfilling diagnostic criteria of ROME III criteria for functional constipation, Patients irrespective of sex, caste and religion, patients willing to provide informed consent 
 
ExclusionCriteria 
Details  Patients not fulfilling the diagnostic criteria.
Pregnant and lactating women
Patients of other gastro-intestinal diseases like IBS etc.
patients having life threatening disorders like malignancies, renal failure, cardiac failure.
patients having other co-morbidities like hypertension, diabetes mellitus, hypothyroidism etc.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Zandu Nityam Tablet is non-inferior to Zandu Nityam Churna in improving bowel movement frequency and stool consistency
2. Zandu Nityam Tablet has a comparable safety profile to Zandu Nityam Churna 
6 months
Period required for pre-trial preparation: 45
Period which may be needed for collecting the data: 3 months
period that may be required for analyzing the data: 1 month
period that may be required for submitting final report: 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of patient satisfaction with the treatment, including ease of use, preference for tablets vs. churna, and perceived effectiveness.  6 months
Period required for pre-trial preparation: 45
Period which may be needed for collecting the data: 3 months
period that may be required for analyzing the data: 1 month
period that may be required for submitting final report: 15 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   14/02/2025 
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="0"
Months="6"
Days="0" 
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  

BACKGROUND

 Constipation is a heterogeneous, multifactorial disorder. Patients with constipation present with a varying set of symptoms, including infrequent bowel movements, defecatory disorders, and hard stool consistency. The prevalence of constipation is approximately 16%, with female predominance, and increases with age. Although it is not fatal in most cases, chronic constipation can result in decreased work productivity, impaired quality of life, and increased healthcare costs.

Guidelines recommend a stepwise approach for the management of constipation. After initial lifestyle modifications, bulking agents and osmotic laxatives are recommended as first-line pharmacologic treatments. However, more than half of patients are not sufficiently satisfied with their treatment. Patient satisfaction with treatment varies, and alternative conservative management is widely used by patients with constipation.

 Malavrodha is a condition caused by vitiation of Vata Dosha especially Apana Vata along with Agnimandya. Malavrodha as a separate disease entity is not mentioned in the Ayurveda classics, but described as either symptom or complication in association with many diseases. Vata Prakopaka Ahara and Vihara are the prime causes of Malavrodha. This can be understood as improper dietary habits and lifestyle and constant mental stress that results in disturbances of Agni and Apanavata. Agnimandya and Apana Vata Dushti are invariably present in the Samprapti of the Vibandha along with derangement in the function of Pachaka Pitta, Avalambaka Kapha and Samana Vata. Early intervention, dietary modifications like fiber rich food, proper toilet training helps to relieve constipation and prevents further complications.

 Nityam churna & Nityam Tablet are well-known Ayurvedic product being marketed in India to overcome the symptoms of functional constipation. Both the products contains standardized Ayurvedic ingredients. The major ingredients are Triphala, swarnapatri, eranda taila, saunf, sanchal along with other Ayurvedic ingredients, which are well known to have laxative properties and helps to improve intestinal movement, maintains gut health, eases bowel movements, soothes the intestine, relives intestinal cramps, cleanses colon and relives stomach bloating.



Study Title:

Evaluation of the Safety & Efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam churna in the management of Malavrodh w.s.r.t. functional Constipation: A RCT


Type of study

Drug trial –Poly herbal Ayurvedic medicines


Study Design

Single Centre, Randomized, Open label, control clinical trial.


Objective

Primary Objective

To evaluate the efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation

 

Secondary Objective

To validate the clinical efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam Churna on the basis of scientific parameters in the patients suffering from Malavrodha w.s.r.t. functional constipation.

To evaluate the safety of Zandu Nityam Tablet & Zandu Nityam Churna in the patients suffering from Malavrodha w.s.r.t. functional constipation.

To compare the efficacy of Zandu Nityam Tablet with Zandu Nityam Churna

 

Duration of study

6 Month

Period required for pre-trial preparation: 45 days

Period which may be needed for collecting the data: 3 months

Period that may be required for analyzing the data: 1 month

Period that may be required for submitting final report: 15 days

 

Sample size

Total 60 complete cases


 
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